Specialist, Engineering Resume Sample
Brooks Trantow
5766 Aufderhar Roads,
Phoenix,
AZ
+1 (555) 376 5119
Work Experience
Specialist, Engineering
10/2017
-
PRESENT
Boston, MA
- Analyzing complex processing problems through critical analytical thinking and the design/execution of laboratory/pilot scale experiment
- Working with the Technology, Automation, and Quality functions to determine the breadth and scope of investigations to identify the appropriate root cause, implement corrective actions, complete trending analysis, and determine product disposition
- Preparing and/or provides guidance and review for regulatory filings, process descriptions, investigations, and change requests. Acts as a participant in domestic and international regulatory agency inspections
- Keeping his/her supervisor current on the progress of projects, and making improvement recommendations on production procedures
- Lead complex manufacturing investigations for all aspects of Barrier Operations formulation and aseptic filling processes. Serve as a technical reviewer/approver for investigations and significant process changes
- Author and execute investigational and/or experimental protocols to generate data to support manufacturing routine or process validation/comparability activities. Ensure all technical writing meets requirements for manufacturing, compliance, and regulatory audiences
- Manage end-to-end process improvement projects with the goal of improving right-first-time execution, reliability, and decreasing the cost of goods sold
Senior Specialist, Engineering
05/2013
-
06/2017
Houston, TX
- Link with key functional leads on site and above site to provide input on behalf of the site team
- Take a leadership role in regulatory inspection activities for the facility through presentation of the team's work to multiple regulatory agencies throughout the life cycle of a process
- Providing on-the-floor support of operational and technical issues; collaborating with the shop floor to provide immediate responses to deviations and potential deviations
- Conducting real time investigations with the goal of fully understanding root cause and product impact within five days of event discovery
- Performing customer complaint investigations, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc
- Completing projects to improve the performance of our processes, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and continuous improvement projects that seek to improve yield, reduce cost, or lower our processing cycle times
- Preparing source documentation for regulatory filings, supporting requests for regulatory inspections related to process overviews, investigations, projects and validation
- Authoring updates to Master Batch Records (production process descriptions) and SOPs (Standard Operating Procedures)
- Supporting team safety, environmental and compliance objectives
Senior Specialist Engineering
08/2009
-
04/2013
Phoenix, AZ
- Managing investigation, project and validation study timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible
- Executing projects and assigned studies in a right-first-time manner
- Provide on-the-floor support of operational and technical issues; collaborating with the shop floor to provide immediate responses to deviations and potential deviations
- Conducting real time investigations with the goal of fully understanding root cause and product impact
- Actively using and championing the use of Lean Six Sigma (LSS) and our organization's Production System (MPS) tools, both in problem solving and day-to-day operational activities
- Responsible for: Plant, Uninterruptible Power System, Automatic Transfer Switches, Generator Paralleling Gear, Building Management System, Boilers, Hot Water Heaters, Air Handlers, Economizers, Exhaust Fans, VAV’s, Under-floor Air Distribution Systems, Chemical Treatment, Fire Detection and Suppression Systems and Elevators
- Develop a best practices approach to services provided, including establishment of metrics/KPI’s and associated benchmarks
Education
Kettering University
2005 - 2009
Engineer's Degree in Chemical Engineering
Professional Skills
- Strong problem solving skills and a hands-on approach to problem solving, with a bias toward addressing issues in a hands-on manner, in the field
- Demonstrated effective written and verbal communication skills as well as ability to influence peers
- Have problem solving skills and a hands-on approach to problem solving, with a bias toward addressing issues in a hands-on manner, in the field
- Experience with technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols
- Work effectively across boundaries to build strong collaborative relation with internal partners, Manufacturing Sites and external partners
- Six sigma and/or lean manufacturing skills
- Experience in engineering or operations with 5+ years experience related to vaccines or biologics
How to write Specialist, Engineering Resume
Specialist, Engineering role is responsible for interpersonal, manufacturing, technical, software, engineering, design, computer, organization, analytical, training.
To write great resume for specialist, engineering job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Specialist, Engineering Resume
The section contact information is important in your specialist, engineering resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Specialist, Engineering Resume
The section work experience is an essential part of your specialist, engineering resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous specialist, engineering responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular specialist, engineering position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Specialist, Engineering resume experience can include:
- Experience in writing Incident Reports, Operational and Emergency Procedures, Functional Test Scripts and MOP’s for all MEP Building Infrastructure Systems
- Demonstrated communication, project management and leadership skills
- Excellent technical, organizational, interpersonal, collaborative and verbal/written communication skills are required
- Excellent collaboration and engagement as a team player with dependable interpersonal and communication skills
- Knowledgeable about engineering tools and skills with technical software
- Computer skills in Word, Excel, PowerPoint, and Outlook
Education on a Specialist, Engineering Resume
Make sure to make education a priority on your specialist, engineering resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your specialist, engineering experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Specialist, Engineering Resume
When listing skills on your specialist, engineering resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical specialist, engineering skills:
- Proven technical communication (written & presentation) skills
- BS/MS in chemical engineering, the biological sciences or related discipline with solid academic record and/or relevant work experience
- Applies technical skills to align activities with department objectives
- Demonstrated project management capabilities and change control experience
- Ensuring an effective sterility assurance and environmental monitoring program is deployed
- Experience with an equipment life cycle approach including specification, selection, testing & commissioning, troubleshooting and qualification
List of Typical Experience For a Specialist, Engineering Resume
1
Experience For Senior Specialist, Engineering Resume
- Good communication and advanced project management skills
- Project management skills within the resources sector on multi-disciplinary projects
- Strong problem solving ability in resolving complex problems and errors arising during difference in CMM inspection methods at vendor and in-house
- Author and updates technical and manufacturing documents to support process changes, investigations, engineering/demonstration work, and validations
- Experience authoring technical documents supporting regulatory filings (IND, BLA)
- Experience in Pharmaceutical/Biotech industry in engineering or manufacturing of vaccines or biologics
- Experience with technical writing (i.e. investigations, change requests, standard operating procedures, batch records, protocols)
- Technical writing experience, (i.e. investigations, change requests, standard operating procedures, batch records, protocols)
- Lead and/or work as a team member to complete manufacturing investigations, process improvement and/or validation projects
2
Experience For Specialist Engineering Resume
- Demonstrated ability to influence and build relationships with a range of stakeholders at all levels of a business
- Performing validation assessments for proposed changes impacting the qualified processes
- Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation
- Experience with sterile processing
- Experience with possessing protein purification and/or technical support
- Process data monitoring experience
- Vaccine formulation and filling experience
3
Experience For Senior Specialist Engineering Resume
- Experience participating in regulatory inspections
- Strong technical and economic competencies
- Experience with Clean-in-Place and Sterilize-in-Place systems
- Experience with Quality by Design (QbD)
- Experience with face to face presentation of technically complex subjects to regulatory inspectors
- Experience with Trackwise, MIDAS, SAP, Delta V
- Experience with tech transfer
4
Experience For Senior Specialist Engineering Processes Resume
- Experience in a GMP-related environment
- Root Cause Investigation experience
- Demonstrated competency in business process improvement, capital planning or project management
- Strong knowledge in scheduling and IT tools, data and analytics
- Experience with troubleshooting biotech and manufacturing equipment
- Experience with large molecule purification (chromatography, filtration, centrifugation)
- Experience with executing projects in qualified production facilities
5
Experience For Specialist, Engineering Deviation Management Resume
- Strong Understanding of Change Control
- Emerson DeltaV DCS experience
- Merck change control experience/expertise
- CMC / regulatory submission experience
- >5 years of relevant parenteral and/or pharma experience with a BS
- >2 years of relevant parenteral and/or pharma experience with a MS
- Experience with Trackwise, MIDAS, SAP
6
Experience For Senior Specialist, Engineering Ops Resume
- LSS/MPS certification / experience
- Experience with capital projects that followed a stage gate capital management process
- Adapts and implements departmental plans and priorities based on department and site scorecard to address local business, service and operational challenges
- Understanding of hygienic design and unit operations specific to vaccine/biologic manufacturing and aseptic processing
- Functioning as a project lead of the technical operations lab team through executing lab-scale process optimization,and investigation support for cell culture
- Functioning as a key team member to collaborate with manufacturing teams to support facility activities and to support area objectives
7
Experience For Product Development Specialist Engineering Resume
- Working understanding of process risk assessment tools
- Monitoring energy consumption and recommends strategies for energy efficiency and greenhouse gas reduction projects
- Identifying spare parts and stand-by equipment needed to assure maximum capacity and reliability
- Supporting positive safety culture and participates in HAZOP reviews and Safety inspections
- Promoting open communication, inclusion and teamwork
8
Experience For Specialist, Engineering Resume
- Larning new processes and procedures
- Serve leadership and supporting roles providing technical support for in-line manufacturing processes
- Work with the site wide facility contractor by providing direction and technical insight regarding the given project, as required
- Possesses an understanding of supporting processes associated with operations and maintenance of a plant
- Knowledge in reliability engineering (including asset life cycle management)
- Work with construction trades and on-site maintenance groups to provide guidance and clarity during construction phase of the project
- Provides technical support to Infrastructure Group, and other site departments, as needed for troubleshooting, repairs and upgrades
- Provide process engineering support to new drug substance products intended for new product launch facilities
9
Experience For Senior Specialist, Engineering Resume
- Author technical documents to support regulatory filings including technical reports and risk assessments
- Schedule, and manage the execution of projects designated as BT Works projects
- Read and interpret drawings such as blueprints, PFDs, P&IDs, AutoCAD, PLC
- Provide on-floor support for all Production activities
- Authors/Supports process changes, batch records and procedural updates
- Responsible for process system improvements
- Works with floor personnel to develop and implement standardized work
- Supports process deviation investigations to provide meaningful immediate and preventive actions and reduce the deviation generation rate
10
Experience For Specialist Engineering Resume
- Provide project engineering and management support to internal capital and expense projects for Elkton Site as assigned, including scope development, estimating, budget, scheduling, and project management of design, construction, and commissioning validation support
- Manage internal and external engineering firms on the design and install of projects
- Work with maintenance planners to implement the necessary PMs, turnover documentation, and required spare parts so that the systems or equipment can be established as a reliable asset
- Prepares engineering reestimate reports
- Provide leadership when safety, environment, or standard work requirements are not followed, so as to address issues in real time
- Manage conflict or disagreement between owners and contractors on design, install, and final completion of a project
- Provide project engineering and management support to internal capital and expense projects for Elkton Site as assigned, including budget, scheduling, and project management of design, construction, and commissioning validation support
List of Typical Skills For a Specialist, Engineering Resume
1
Skills For Senior Specialist, Engineering Resume
- Experience with on-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and potential deviations
- Contract and contractor management experience, including drafting, negotiation, tendering and variation management
- Work experience in a medium volume /mix electro-mechanical manufacturing or production environment with an emphasis on manufacturing processes
- Two (2) years relevant work experience, including manufacturing technical support or development of biologics / sterile products
- Two years relevant work experience, including manufacturing technical support or development of vaccines/ biologics / sterile products
- Experience in secondary packaging of sterile products
- B.S. or M.S. in Chemical Engineering, Chemistry, Biology, Biochemistry or comparable discipline, with 2 years (BS) or 0 years (MS) of relevant experience
- Experience leading departmental or cross-functional teams
- Experience in vaccine or biologics drug substance manufacturing within an aseptic, cGMP environment
2
Skills For Specialist Engineering Resume
- Experience authoring technical documentation within a cGMP context
- Experience in a similar project engineering position
- Excellent command of English (both written and oral)
- Experience with project strategic plan development and management
- Providing technical support for vaccine manufacturing and sterile supply in the form of protocol/report writing, troubleshooting, and problem solving
- Assisting the project manager for small projects including scope development, design support, field execution and commissioning testing
- Authoring Standard Operating Procedures and job plans and assisting in training development for mechanics and supervisors
3
Skills For Senior Specialist Engineering Resume
- Assisting operations and mechanics in troubleshooting equipment problems as well as investigating system failure or malfunction
- Supporting maintenance scheduling and planning processes in area of responsibility
- Assisting with certified shipping and receiving personnel
- Functioning as a key team member to collaborate with bulk manufacturing teams to support area objectives
- Leading and facilitating ad-hoc, not common practice projects across the whole of BMA
- Assisting in executing maintenance and repair strategy for annual shutdowns
- Assisting in the preparation of process studies, engineering standards, equipment utilization, and profit plan
- Explaining and enforcing all safety and environmental regulations
- Assisting in audits, regulatory inspections and training in the area of responsibility
4
Skills For Senior Specialist Engineering Processes Resume
- Executing assignments against critical-path timelines in a right-first-time manner
- Authoring technical documents to support process optimization and investigation support
- Participating in technical support activities for licensed vaccines, as needed.
- Interfacing directly with the operations shop floor to ensure reliable supply of product to our customers
- Technical understanding of key mining equipment including but not limited to trucks, excavators, shovels and Coal processing plants
- Manage the planning, safe execution, and commissioning of approved Engineering Projects and deliver work on scope, schedule, cost and safety targets
- Work independently as a team member on a deviation management team, including leading investigations and CAPAs
- Responsible for maintaining and controlling all the ECN records
- Take responsibility for creating and maintaining plant technical documentation
5
Skills For Specialist, Engineering Deviation Management Resume
- Leads and/or works as a team member on manufacturing investigations and/or process improvement projects
- Assures consistent application of standardized work, engineering and process tools
- Provides technical support to manufacturing shop floor for problems and issues
- Conducts and designs experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale
- B.S. or M.S. in Chemical, Mechanical, Industrial Pharmacy or other related engineering/scientific fields
- Responsible for the development of staff engineers and scientists by acting as a formal mentor
- Ensure all regulatory requirements (cGMP, Safety, and Environmental) are met during all phases of the design and construction of the project
6
Skills For Senior Specialist, Engineering Ops Resume
- Provides engineering services listed above for larger and/or more complex projects with some deviation from standard practices if required
- Leads or supports project design efforts, providing innovative solutions that meet business objective
- Provides technical guidance during project implementation, assures viability of technology in proposed configuration
- Assist in creation of new bills of materials and maintain current engineering documents
- Participate in New Product introduction and facilitate product introduction to manufacturing
- Understand and interpret regulations and their impact on the Company’s operations
- Functioning as a key member of the technical services lab team through executing lab-scale process optimization, and investigation support for cell culture and downstream processing
- Anticipates and interprets client and/or customer needs to identify and implement solutions
- Has ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
7
Skills For Product Development Specialist Engineering Resume
- Experience with washers and autoclaves
- Conducts and Design experimental protocols
- Realization of a new, state-of-the-art bulk sterile antibiotic facility to include
- Support of vaccine operations and product franchise technical services support
- Willingness to travel to internal and external sites within Europe up to 25%
- The position requires strong technical writing skills, knowledge of potential product/package interactions and basic understanding of the use of Design of Experiments (DOE)
- Combination product experience is desired
8
Skills For Specialist, Engineering Resume
- Hands-on expertise with lab or pilot-scale culture process (fermenters, bioreactors, static cell culture) and/or with large molecule purification (chromatography, filtration, centrifugation)
- Technical knowledge and experience with cell culture, virus propagation, and/or large molecule purification
- Experience in new product introduction and technology transfer
- Experience with process control systems, e.g. Distributed Control Systems
- Provide scientific mentorship and guidance to technical colleagues
9
Skills For Senior Specialist, Engineering Resume
- Analyze complex data and solve problems
- Project accountability to execute Technology Transfer and on-going process; support and highlighting the need for the leveraging of shared resources from the Science and Technology network
- Together with the Tier 2 team (Ops Q, tech), establishing a calibrated technical oversight approach based on the product type as well as the capabilities and technical competence of an external partner
- Together with the Tier 2 team (Ops, Q, tech), establishing clear expectations, measures and periodic monitoring of operational and quality performance associated with external partners in the region
- Participating in periodic Business and Relationship Review Meetings (as appropriate) with partners
- Assignment to participate in Technical due diligence assessments
- Tracks and analyzes projects’ performance, expenditures, procurement and reports about any possible or, risks, overflows, deficits
- Interface with site clients ensuring understanding of all GFM Engineering strategies, projects and matters relating to the delivery of the GFM portfolio. Proactively initiate actions that add value through innovation and operational excellence. Assist in the building of sponsorship and support for GFM and IFM strategy
10
Skills For Specialist Engineering Resume
- Assist the FM Lead to partner with site leadership and strategic sourcing providers (IFM - Integrated Facilities Management), to implement FM initiatives in line with agreed scope and local regulatory and employee consultation processes
- Project management skills within a resources or industrial sector on multi-disciplinary projects
- Assisting with glass wash and hazardous materials management program
- Receive feedback from stakeholders to inform the respective governance processes integrating feedback into service standards
- Attend regional Facilities, meetings as required to ensure alignment with and contribute to global and regional strategies and initiatives. Represent issues and concerns affecting local activities
- Deputise for the FM lead in attending site leadership meetings to represent Facilities, in key decision-making relating to the workplace and all matters in the FM portfolio
- Participate in the MMD / FM council sharing best practice and supporting the continued development of the GFM model
List of Typical Responsibilities For a Specialist, Engineering Resume
1
Responsibilities For Senior Specialist, Engineering Resume
- Approving protocols for validation of cleaning, sterilization, thermal and manufacturing processes
- Support internal and external engineering firms on the design and install of projects
- Designs primarily small project building automation network architecture to support operator workstations, DDC field panels, and third party integration devices connected through LON, Ethernet, Siemens P2 or BACNET
- Support the development and bench marking of IFM provider projects
- Design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale
- Develop and assures consistent application of standardized work, engineering, and process tools
- Establishes special calibration instructions on selected equipment
- Adhere to Ferro’s Core Values and Behaviors
- Complete analysis of complex problems through critical analytical thinking and the design/execution of laboratory/pilot scale experiments when required
2
Responsibilities For Specialist Engineering Resume
- Knowledge and understanding of parenteral dosage forms and delivery methods, including injection devices for self-administration, secondary packaging requirements, and cold chain distribution practices
- An enthusiasm for collaboration with a diverse set of business partners within research, development, and supply, at a variety of locations within and external to Merck
- Strong interpersonal skills and the ability to manage projects and lead discussions with partners from other functional areas when conducting risk assessments, designing experimental test plans, and seeking to utilize materials and resources outside the control of Packaging Commercialization
- Strong organization and time management skills to allow for the ability to successfully track multiple project assignments at a variety of different stages of development
- Trade background (Boilermaker, Fitter, Electrician) highly regarded
- Implementation of plans and strategies to enhance capital efficiency across BMA
- Risk Assessment facilitation for the delivery of projects across BMA
- Collaborates with a team in the evaluation of alternative solutions and the development of project scope
3
Responsibilities For Senior Specialist Engineering Resume
- Ensures that deliverables conform to Merck standards and practices, and are technically sound
- Team leader for assigned areas of facilities
- Liaises with other technical functions to ensure successful technology transfers of new and in-line products
- Collaborates with contractors, suppliers and other team members in the execution of the work
- Create and maintain part numbers in SAP system
- Assists with the implementation/integration of new technology and documentation processes. Participates in coordination meetings to gain understanding of project scope and offer functional area input. Responds to internal customer inquiries regarding documentation and data sets
- Maintains all the work instructions for all the product types in the manufacturing facility
- Coordinates the administration of departmental budgets. Assists the Engineering Manager in budget procedures and controls
4
Responsibilities For Senior Specialist Engineering Processes Resume
- Work with Operations Manager, Process Engineers, and QA department to develop new product data collection and defect analysis reporting requirements
- Review and keep data of machine efficiencies by analyzing manufacturing process for excessive scrap, machine downtime and poor quality in order to improve downtime, quality, machine productivity and product yields
- Working with integrated facilities management including operations personnel and maintenance mechanics to maximize capacity and assure efficient, reliable equipment operation in accordance with safety and environmental regulations
- Assisting in the preventive and predictive maintenance program, reviews equipment history for reliability concerns, performs root cause analysis, and identifying reliability improvement opportunities and applications for predictive maintenance technologies to reduce maintenance costs
- Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the drug substance process
5
Responsibilities For Specialist, Engineering Deviation Management Resume
- Build SOP’s and Job Plans
- Author technical reports and documents associated with site commercialization efforts
- Support definition and development of process control strategy including identification of critical process parameters and critical material attributes for upstream process and raw materials
- Participate in the equipment specification, selection/procurement, and qualification phases of a project
- Drive continuous improvement to enhance quality and productivity
- Work to identify, evaluate and implement plant / process modifications / projects
- Propose and implement capital projects through successful completion
6
Responsibilities For Senior Specialist, Engineering Ops Resume
- Act as a consultant to customers and management within areas of expertise
- Assure compliance with technical rules and regulations, as well as with company policies, statutes and operational excellence practices
- Validation Lead - Serving as the single point of contact for the coordination of all planned and unplanned validation studies including equipment visual inspections. Coordinate availability of all resources including people, material and supplies to enable right first time execution
- Serving as the lead validation Subject Matter Expert (SME) for bulk polysaccharide vaccines during all regulatory inspections and internal audits. Coordinate with the validation site COE and global groups to ensure area validation program remains current with regulatory expectations
- Leading project teams to implement changes for process improvement, compliance, and strategic, including projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times
- Authoring and/or approving Change Control documentation for complex process, validation, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines
- Preparing source documentation for regulatory filings, supporting and supporting requests for regulatory inspections related to process overviews, investigations, projects and validation
7
Responsibilities For Product Development Specialist Engineering Resume
- Collaborating effectively with the area Coaches, Operators/Mechanics, support groups (Mechanical Services,Automation, Technology), Quality, and Planning
- Project Leadership and Project Execution for both strategic and supply initiatives for critical materials used in vaccine production requiring partnership and collaboration with manufacturing sites across the organization
- Utilizing sound scientific and engineering principles for problem solving and recommendations for changes/efficiencies in raw materials management for select vaccine franchises
- Interacting with vendors, Global Procurement and Supplier Development & Performance Management to improve the quality and supply of raw materials as well as implementation of new and alternate raw materials and/or supply chains
- Providing technical expertise on all sterility assurance aspects and micro contamination control. Travelling to various sites (as necessary) to support/develop process improvement efforts
- Use risk based approaches to evaluate existing manufacturing processes and associated controls with respect to the potential for microbial, endotoxin and particulate contamination
8
Responsibilities For Specialist, Engineering Resume
- Be an effective source of information and advice on sterility assurance to ensure the site maintains a robust, effective and compliant sterility assurance and environmental control monitoring process
- Assist in the defining, development and streamlining of the GWES PMO process and the development of execution tools
- Support analytics around monthly reporting and create and update dashboards and other reporting tools to identify cost and schedule impacts
- Play a role in the development of ongoing internal and external bench marking processes to identify best practices and appropriate KPI's for capital projects
- Responsible for process system improvements regarding sterility assurance
9
Responsibilities For Senior Specialist, Engineering Resume
- Develops to become a SME on Sterility Assurance, Process Simulations and as a primary Point-of-Contact for Regulatory Audits
- Authors/Supports process changes, batch records and procedural updates as needed
- Supports sterility related deviation investigations as needed
- Maintain the GWES Project Management Community of Practice team site
- Provide PMO support as needed to projects globally
- Capture project costs and historical data at the end of a project
- Work with project teams to ensure assets are put in service upon project completion
- Maintain lessons learned documentation
10
Responsibilities For Specialist Engineering Resume
- Identify trends of project safety issues and develop quarterly GWES Project Newsletter
- Review Global Disabilities & Inclusive checklist for all projects
- Effectively collaborates and engages with multiple functional organizations such as Operations, Technology, Quality, Automation, Global Engineering Solutions, Procurement, Finance, Above Site Technology, Regulatory, among others, to develop and maintain processes that meet cGMP and business requirements
- Determine project resource requirements and and timelines, and work with stakeholders to gain support needed from subject matter experts
- Develop and execute change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings
- Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause
- In depth understanding and proven expertise in application of GMP’s, quality systems, especially technical subsystems related to process and equipment qualification, change control, deviation management and cleaning qualification
- Chemical, Electrical or Mechanical Engineering Major
Related to Specialist, Engineering Resume Samples
Controls Engineering Resume Sample
Work Experience
• Review hardware designs for Disney’s ride control systems
• Review software designs for Disney’s ride control systems
• Manage and lead efforts to develop standard maintenance and repair procedures for Tesla’s manufacturing equipment
• Enforces Engineer...
Professional Skills
• Communication skills are strong with the a...
• Experience leading, teaching or managing o...
• MS Office Skills are required (Excel, Powe...
Engineering Fellow Resume Sample
Work Experience
• Technical experience in developing complex software and/or hardware systems for cryptographic systems
• Demonstrated background in System Modeling, System Simulation, and/or Design of Experiments
• Develop solutions to
• Experience directing development...
Professional Skills
• Strong leadership skills and project manag...
• Strong analytical and creative problem sol...
• Excellent communication skills required to...
System Engineering Resume Sample
Work Experience
• Additional planned involvement in cybersecurity-oriented analysis, design in MITRE support of NIST National Cybersecurity Center of Excellence or MITRE’s Cybersecurity Technical Center
• Develop the system engineering force (people, tools, processes) to support business growth of Services across No...
Professional Skills
• Demonstrated experience developing and cre...
• Strong organizational and management skill...
• Demonstrate strong interpersonal skills wi...
Engineer Electromechanical Resume Sample
Work Experience
• · Background in Electro-mechanical design is an asset
• · Electro-mechanical design and product development is an asset
• · Basic understanding of railway Rolling Stock both theoretical and practical
• Develop product drawings and models. Manage the mod...
Professional Skills
• Independent working ability; strong initia...
• Computer skills: e.g. .net programming skills
• Strong technical problem solving skills (i...
Assistant Director Engineering Resume Sample
Work Experience
• Stationary Engineer’s license if required by local code
• The worker is subject to noise: there is sufficient noise to cause the worker to shout in order to be heard above the surrounding noise level
• The worker is subject to vibration: exposure to oscillating movements of t...
Professional Skills
• Excellent customer service skills with gre...
• Demonstrate strong leadership, good interp...
• Demonstrated skills in effective budget an...
Engineer Service Resume Sample
Work Experience
• Install, configure, and upgrade nodes in high availability customer production clusters
• Build long lasting, effective partnerships across the organization to foster collaboration between Product, Engineering and Operations teams
• Organize and manage multiple simultaneous p...
Professional Skills
• IT experience in an IAAS / PAAS environmen...
• Previous experience with Network Administr...
• Very good verbal and written communication...