Validation Manager Resume Sample
Easter Lemke
461 Stehr Plain,
Houston,
TX
+1 (555) 878 2051
Work Experience
Validation Manager
09/2016
-
PRESENT
Detroit, MI
- Providing validation assessments to determine scope of validation needed for automation, equipment, facility, utility changes for Shire’s internal manufacturing operations
- Independent, proactive, accountable and self-contain is needed
- Great interpersonal skills and capable to motivate the team is mandatory as huge challenges ahead of us
- Excellent collaboration between teams is needed as the team is remote from the majority of the rest of the Validation team
- From the QA process, engage different parties within the business to determine next steps, requirements, and ensure completion of the CAP on a timely basis
- Develop recommendations to strengthen IPB U.S.’s internal controls and improve operational efficiency. Includes performing ongoing analysis of trends in CAP management
- Establish strong working relationships across IPB U.S. businesses
Senior Validation Manager
04/2012
-
08/2016
Boston, MA
- Work closely with CAP Coordinators and Compliance colleagues across the business to identify and raise emerging issues and opportunities
- Comfortable with data entry tasks to assure updates to corporate systems (i.e. iCAPs)
- Experience with data manipulation and analysis using excel
- Applies solid understanding of Internal Audit validation practices to accomplish the objectives of the function
- Develop understanding of end-to-end process, risk and controls framework to determine effectiveness of controls design
- Partners with Business/CAP owners to ensure that closed CAPs are correctly documented in corresponding corporate systems (currently iCAPS)
- Act as validation reviewer for operation's SOP's with validation cycle parameters and possess ability to quickly address operations’ issues with equipment validated cycles
- Update and maintain validation SOP’s for conducting all validation work to include: sample preparation, sample collection, sensor calibration, and final report documentation packages
Software Validation Manager
05/2006
-
03/2012
Philadelphia, PA
- Exempt personnel supervision experience
- Facilitating team efforts on quality and manufacturing engineering projects
- Multitask, meet deadlines and be results oriented
- Ability/knowledge and expertise with medical device process, system, method, equipment & software validations
- Understand critical to quality, fault tree tolerance and safety and integrity levels
- Education equivalent to a university program certificate in Chemical Engineering or related field or equivalent combination of education and experience
- Read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to communicate to a group of individuals through oral or written forms
- Knowledge of manufacturing processes and methods for cost-reduction, quality improvements, and efficiency
Education
University of Pittsburgh at Bradford
2001 - 2005
Engineer's Degree in Engineering
Professional Skills
- Possess a strong knowledge of the principals of process and cleaning validation, current industry approaches, cGMP and the FDA validation guidelines
- Oversee validation functions including but not limited to media fills, new product / process validation, and cleaning validation
- Prioritize and manage the overall validation resources (staff, equipment, and funds) to meet diverse and aggressive goals for validation compliance
- Working experience in reviewing/development of URS, Tendering, preparation of technical comparisons, DQ, FAT, SAT, commissioning, qualification and validation
- Significant experience planning, deploying, managing and sustaining validation or technical service operations in a sterile dosage pharmaceutical facility
- Technical documentation authoring and editing skills
- Demonstrated knowledge and experience of cleaning processes
How to write Validation Manager Resume
Validation Manager role is responsible for interpersonal, leadership, english, documentation, manufacturing, finance, training, integration, database, mac.
To write great resume for validation manager job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Validation Manager Resume
The section contact information is important in your validation manager 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 Validation Manager Resume
The section work experience is an essential part of your validation manager 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 validation manager responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular validation manager position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Validation Manager resume experience can include:
- Knowledge in the fields of science and engineering with the ability to apply these concepts to define problems, collect data, establish facts, deal with concrete and abstract variables, and draw valid conclusions
- Knowledge of cGMP guidelines, international regulations as well as current good industry practice pertaining to the production of APIs and drug products. Guidelines include ICH Q7, CFR, USP and the EudraLex
- Effective problem and conflict resolution skills and proven team focus
- Experience in validation systems, change control and a proven track records in effectiveness
- Experience with product development processes and project management skills are required
- Good communication skills both internally and externally
Education on a Validation Manager Resume
Make sure to make education a priority on your validation manager resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your validation manager 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 Validation Manager Resume
When listing skills on your validation manager 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 validation manager skills:
- Knowledge of engineering terminology together with strong technical report writing and excellent communication skills
- Critical thinking and demonstrated problem solving / root cause investigation skills
- Facilitate the Plant Validation Steering Committee to gain consensus on priorities and schedules, which consolidates the compliance and business needs
- Strong organizational, leadership, communication and problem solving skills
- Experience in Validation in a Pharmaceutical company with experience including 2-5 Years in a Supervisory / Managerial Position
- Strong management, collaboration, training and communication skills (especially at senior management level)
List of Typical Experience For a Validation Manager Resume
1
Experience For Senior Validation Manager Resume
- Communicate effectively and accomplish goals while working across functions and organizational levels is required
- Development and execution of validation test plans, designing test boards, writing test firmware & software, and building system-level configurations
- In manufacturing, quality assurance, and/or software engineering/validation in an FDA-regulated environment
- Be involved in the Implementation of a risk based approach to the validation of systems including computerised systems residing in Thetford
- External Contacts – Liaise with suppliers and vendors inputting to the validation of projects being handled
- Contribution to maintaining and periodically evaluating the qualification/validation/part11 status of equipment, systems, products and processes
2
Experience For Computer System Validation Manager Resume
- Operational experience and a broad understanding of a range of processes in delivering logistic services
- Leads validation staff to execute upon the following responsibilities
- Responsible for providing strategic and tactical leadership for the Validation Department
- Provide technical validation training to plant personnel
- Leads team in the execution of validations as necessary to support Quality Assurance & Manufacturing Projects
- Provide employees with the necessary guidance, counseling, and tools to perform validations
- Generate, review, approve, and execute process, facility, and cleaning validations
- Participate in peer technical review of process and cleaning validation documents developed and executed by others
3
Experience For Software Validation Manager Resume
- Lead groups in creation of requirements documents, risk assessments, process and cleaning validation
- Evaluate and analyze validation data collected during projects, verify adequacy of the data and compliance with regulatory requirements
- Work on multiple projects and initiatives simultaneously with shifting priorities
- Generates, revises and approves documentation for validation studies ensuring compliance with QA and cGMP systems
- Responsible for site training on the validation program
- Run validation project execution DQ/IQ/OQ/PQ in conjunction with relevant stakeholders ensuring timelines are met and deliverables achieved
4
Experience For Engineering & Validation Manager Resume
- Train staff in validation procedures and principles during execution activities
- Responsibility for planning, coordination, execution and follow-up of qualification and validation activities
- Spokesperson during internal and external audits for qualification/validation of “operational” equipment, systems, products and processes
- Responsibility for the qualification/validation budget including costs charged to projects / clients
- Perform system-level verification prior to production release to identify problems
- Define, develop, and/or acquire software and/or hardware tools in support of silicon validation efforts
- Provide mentorship and guidance to less experienced team members
5
Experience For CCB Remediation & Correction Code Validation Manager Resume
- Up to date knowledge of validation strategies for Cloud Solutions, SaaS, Iaas
- Demonstrated successes in a team environment, such as project teams, Six Sigma team, Tier 4’s etc
- Validation of server features in cluster test environments
- System owner of the site’s validation program; defines and revises procedures to ensure compliance to cGMP, GLP, FDA and worldwide regulations
- Seeking accountability and driving major changes in a sustained manner
- Working knowledge of Digital Signal Processing, Audio fundamentals, use of common lab equipment such as oscilloscopes and multimeters
- Leading projects to develop and coordinate testing procedures for prototypes and products
- Working knowledge of LC development tools such as HPALM or HP Quality Center
- Understanding of global and corporate dynamics
6
Experience For Silicon Validation Manager Resume
- Leading the Human Factors/Usability project
- Preparing the system V&V master plan with accordance to the FMEA, design requirements and applicable standards
- Assist engineering with equipment qualifications by participating in FATs, commissioning activities, SATs, and IOPQ events
- Provides leadership for engineering projects from concept through design, implementation, testing, documentation, support, and maintenance
- Enables and/or performs silicon characterization and functional testing through the development of robust and reusable tests
- Maintain and analyze characterization data to ensure that the data matches design goals while also identifying potential problems in production
- Provides guidance, mentoring, and direct supervision to subordinates
7
Experience For Verification & Validation Manager Resume
- Oversees interaction of team members with other disciplines (design, applications, and product and test engineering)
- Contribute to the formulation and ongoing evolution of MRMG’s practices and procedures along with other MRMG managers and the Chief Model Risk Officer
- Knowledge and working application of FDA cGMP/GCP regulations, ANSI/ISO standards, GAMP 5, and 21 CFR Part 11/820
- Knowledge and working application of FMEA and Risk Analyses
- Support development of department’s annual operating budgets; partner with Finance to analyze variances and implement adjustments as needed
8
Experience For Validation Manager Post Si Validation Resume
- Ensures existing practices comply with industry standards
- Manage a team of people both reporting directly and indirectly into this role
- Act as the Quality Lead for one or more major revenue earning clients
- Prepare written and oral capital equipment proposals, status reports, training outlines, and other communications
- Work with engineering service providers to scope, schedule and quote work packages
- Work with design teams to isolate design errata, perform failure analysis, and verify design fixes
- Develop automation scripts to automate data collection, decrease data collection times, ensure repeatable measurements, and generate reports
9
Experience For Coherency IP Validation Manager Resume
- Builds sustaining engineering competencies within the validation team to support existing products, assist the applications group, identify root causes of problems, and PG identified fixes
- Communicates technical information to senior members of the management team
- Conducts annual performance reviews of direct reports
- Recruits, selects, develops, and motivates the best engineers to ensure the efficient operation of the function
- Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals. Provide guidance to subordinates within the latitude of established company policies. Recommends changes to policies and establishes procedures that affect immediate organization(s)
10
Experience For Method Validation Manager Resume
- Substantial knowledge and experience of global regulatory requirements and cGMP compliance related to biologics manufacturing, laboratory practices, aseptic filling, contamination control and combination products
- Extensive knowledge and experience of Drug Product and Final Drug product manufacturing, equipment, utilities, facilities, engineering and instrumentation
- Develop, articulate, author and defend validation strategies and plans for our products and facilities
- Technical understanding of compliance issues specific to one or more of the technologies in the RDC ecosystem is a requirement (Force.com, SAP, MS Office, WinChill, etc.)
- Good communication, project management and collaboration skills (at all levels of an organization)
- The ability to clearly explain MRMG’s validation work to regulatory staff and external auditors
- People and third party management
- Experience in the medical device/IVD or biotech/pharmaceutical industry in software/system validation, quality management, process controls, and continuous improvement methods
- Lead a team of validation engineers to successfully prioritize and manage multiple projects across several product lines
List of Typical Skills For a Validation Manager Resume
1
Skills For Senior Validation Manager Resume
- Proven ability to effectively recruit, manage, and retain employees
- Experience in GMP manufacturing environment in Engineering, Quality or Validation Medical Device/Pharma background
- Or more of practical functional validation experience including test plans, test infrastructure, and test development
- Participates in risk assessments that identify potential critical process parameters and key operating parameters to prioritize validation activities
- Responsible for supporting documentation systems and archives to evidence compliance, validation, risk assessments and change control
- Demonstrated track record in delivering an efficient and integrated approach to validation management and execution
- EU/APAC: Significant proven experience in software testing
- Substantial knowledge and experience managing qualification and validation practice across the life cycle of biologics products
2
Skills For Computer System Validation Manager Resume
- Develop and provide validation training to cross functional teams to improve product, process and foundational validation knowledge process
- Experience managing a team of validation and/or emulation engineers
- Experience of hands on validation of SOC products
- Constantly seek to develop skills of others and self. Coaches individual within the team
- Extensive validation experience in a pharmaceutical or other highly regulated environment
- Demonstrated knowledge and experience in process systems associated with the manufacture of a biopharmaceutical product
- Demonstrated knowledge and experience in clean room qualifications
- Experience in validation environment in a leadership role
3
Skills For Software Validation Manager Resume
- Hands-on experience and a track-record of success in pre-silicon validation to provide basis for management judgment and schedule management
- Three (3) years of experience with validation of biopharmaceutical processes
- Experience in Software Validation and Medical Devices
- Accountable for maintaining the Site Master Validation Plan and inventory of all site validations
- Other tasks as necessary to maintain the effective functioning of the Validation teams across site as required by the Quality Director
- Ensure validation projects are adequately resourced by allocating internal and external validation resources as required
- Oversee and manage validation contract resources including work prioritization, execution, and contractor budget
4
Skills For Engineering & Validation Manager Resume
- To propose and agree Revenue and Capital Budgets necessary to carry out the agreed validation programme and to operate within those agreed budgets
- Programming experience using C, JAVA and scripting languages is required
- Maintaining and enhancing the SoC and Silicon validation flow aiming for higher quality and efficiency
- Planning and writing Verification and Validation protocols for a medical device throughout all development and production stages of the product
- Developing testchips from netlist to tape-out for validating IPs
- Leading the company Verification and Validation activity
- Performing Verification and Validation tests of HW and SW for prototypes and products
5
Skills For CCB Remediation & Correction Code Validation Manager Resume
- Helping the business in the definition and assessment of IT Quality & Validation requirements
- Working with business and IT partners to ensure RDC IT quality & validation practices are aligned with regulatory expectations and industry best practices
- Liaising with business quality units to inform of IT Quality & Validation process governance and RDC IT Quality Solutions
- Provide technical support in resolving process and cleaning validation related deviations including executing and managing corrective actions
- Responsible for workload forecasting and ensuring effective work processes& procedures are in place and are being followed / used by all the team members
- Experience in change requests, change control, leading, conducting and writing investigations
- Knowledge of Good Manufacturing Practice, Safety, Health and Environment, and Lean manufacturing
6
Skills For Silicon Validation Manager Resume
- A demonstrated ability to influence others to ensure the best outcome while dealing with the pressures of manufacturing and schedule
- Provide coaching on process and cleaning validation topics
- Lead the Validation team, providing training, technical support and guidance
- Assist in directing the activities and overseeing validation contractors
- Provides training on systems implementation and validation SOP’s
- Management experience of SW & HW engineering resources
- Experience in the development of automated test systems using laboratory equipment
7
Skills For Verification & Validation Manager Resume
- Experience as direct interface with FDA and other external regulators during inspections
- Experience required of working to cGMP and Annex 11 and 15 framework
- Responsible for identification and resolution of roadblocks, and streamlining of the validation effort where possible
- Experience working in Medical software as QA Engineer
- Work with engineering service providers to recruit and train validation engineers to address surges in work demand
- Support the National QA Manager in driving the Validation and QA agenda
- Develop or assist the Director or designee with developing metrics to qualify and quantify the health of the Validation department
8
Skills For Validation Manager Post Si Validation Resume
- Report or assist the Director or designed with reporting Validation department metrics information to executive management
- Provide training on systems implementation and validation SOP’s
- Experience in implementing GMPs
- Post-silicon validation, testing, and debug of block functionality on prototype silicon
- Assist in the design and implementation of Process Validation Plans that include Facility, Process, and Cleaning
- Operation of test equipment such as: Kaye validator, fog machine, air sampling equipment
9
Skills For Coherency IP Validation Manager Resume
- Experience managing team to functional and budget targets
- Experience in support of internal and external audits
- Knowledge of current regulatory guidelines associated with validation practices
- Familiar and experienced with relevant systems and applications e.g. TrackWise, PIMs, Sharepoint, Workplace and Saba Cloud document management system
- Provides compliance leadership, direction, and oversight in the area of Computer System Validation
10
Skills For Method Validation Manager Resume
- Clear and effective communication to internal staff and external stakeholders
- Develop and implement mid and long-term validation strategy to drive continuous improvement and ensure reliable supply and compliance
- Good verbal and written communication is required, as well as personal accountability and ownership to follow through with issue closure
- Total number of years' experience required to fulfil the role: 7+
- Serve as a engaged and effective member of the site’s Senior Leadership Team
List of Typical Responsibilities For a Validation Manager Resume
1
Responsibilities For Senior Validation Manager Resume
- Innovative, decisive, results oriented leader with strong coaching and problem-solving skills
- Demonstrated ability to disseminate operational good practice through either coaching or auditing and to delegate
- Significant proven experience in testing various applications developed in Java, .Net, Oracle
- Lead and/or facilitate validation team performance improvements and cross-functional integration effectiveness
- Experienced in embedded software development/validation and project management
- Understanding of QSR/ISO/ICH regulations & validation applicable guidelines, medical device design assurance, FMEA, and product testing methods
2
Responsibilities For Computer System Validation Manager Resume
- Driving the resolution of identified quality & validation gaps and calling out unresolved critical situations
- Experience working in a Healthcare-manufacturing environment – ideally part of which would be in the pharmaceutical sector
- Excellent problem solving and decision - making ability
- Relevant experience in coordinating and performing all aspects of the functions in his/her group
- Quality engineering experience working with high-volume assembly processes
- Utilize quality systems to measure, analyze, and improve the validation engineering system to ensure overall compliance and increased efficiency
- Evidence of a high level of technical understanding of the regulatory requirements of the industry
- Leads, motivates, and coaches up to 5 Validation Engineers of varying expertise in the Oral Dosage Technology Team to drive tasks to completion
3
Responsibilities For Software Validation Manager Resume
- > 5 years’ experience in Pharmaceutical / Biopharmaceutical industry or a similar operating environment
- Responsible for communication and coordination with other departments to streamline the transition of validation projects to routine manufacturing
- Provide technical mentoring and architect validation strategies for the team
- Clearly communicates up, down, and laterally using effective and flexible communication styles
- Relevant experience in successfully managing employees in his/her group
4
Responsibilities For Engineering & Validation Manager Resume
- Relevant experience in successfully balancing multiple projects and timelines
- Experience in liaising successfully with other teams and clients
- Serve as primary interface for validation matters with regulatory and third party representatives and when needed for R & D, technical resources, and vendors
- Understanding of pharmaceutical manufacturing, laboratory and distribution regulations, guidelines, principles and expectations
- Designing according to SIL standards
- Driving and facilitating the creation of relevant QMS related SOPs
- Ensuring the administration of CSV and Project Management Methodology (PMM) Training to RDC internal and external personnel
- Understanding of spice and logic simulation tools e.g. HSpice/HSIM, Verilog
5
Responsibilities For CCB Remediation & Correction Code Validation Manager Resume
- Working knowledge of Microsoft Office products (Outlook, Word, Excel, PowerPoint)
- Working on ladders
- Responsible for interviewing and hiring decisions regarding candidates in his/her group. Also responsible for determining when new positions are needed
- Responsible for monitoring and updating project status and communicating this information to management
- Develop working procedures, Standard operating procedures (SOPs), and training for his/her department
6
Responsibilities For Silicon Validation Manager Resume
- Partner with the Engineering, Technical Services, Manufacturing, and Quality areas to assure all standards, regulations and guidelines are being followed
- Manages personnel functions including hiring, performance appraisal, salary position recommendations and employee development
- A thorough understanding of cGMP pharmaceutical manufacturing requirements and best practices based on FDA, ICH, EU (and others) regulations
- Be proactive in identifying problems and proposing solutions
- Capable of leading cross-functional teams and motivating people
- Communicate, manage people and projects as well as leading and coaching project teams
7
Responsibilities For Verification & Validation Manager Resume
- Listens and responds to varying needs in logical and articulate manner to gain acceptance of an idea or plan
- Challenges current methods and practices offering new ideas and solutions to enhance performance
- Leads cross-functional teams through complex investigations using root cause methodologies
- Read and understand engineering and scientific documentation
- Familiar with common software practices and methodologies (agile techniques, bug tracking and source control systems, etc.)
8
Responsibilities For Validation Manager Post Si Validation Resume
- Familiarity with the following systems: Quick Application Deployment (QAD), ERP, Document
- Support the Data Integrity improvements providing resource and knowledge where required
- A BS/BA in engineering or similar discipline (required)
- Normal office and manufacturing environment
- Have a detailed understanding of GMP, quality assurance and documentation systems in a pharmaceutical environment
- Professional background in a Pharmaceutical Production environment (e.g. Production, Product Introduction, Engineering, Quality Assurance)
- Address quality issues in accordance with ICON Standard operating procedures (SOP’s) and Work Procedures (WP’s)
- Own verification schedules and reporting of progress metrics
- Practical knowledge of ASTM E2500 for specification, design, and verification of manufacturing systems
9
Responsibilities For Coherency IP Validation Manager Resume
- Collaborates to generate innovative solutions using scientific data to solve problems and removes obstacles to achieve department and site goals
- Knowledge of software programming tools and SW development
- Advanced knowledge of EVB kit development including PCB design
- Conducts 21 CFR Part 11 assessments on new and existing computerized systems
- Responsible for qualification and documentation related to engineering department
10
Responsibilities For Method Validation Manager Resume
- Accurate estimation of budget for CAPEX and managing the same within the approved budget
- Achieve results without having direct control over resources
- Manage consultants and set expectations for the quality and timeliness of their deliverables
- Champions continuous improvement of WuXi’s practices, documentation, forms, SOPs, and systems within the IT department (including validation) and throughout WuXi.
- Coordinate evaluation and disposition of quality non-conformances (QNs) and supplier requests for information (SRI’s)
- Manage the site validation program for existing and new products, manufacturing processes, testing, packaging, shipping, facilities and utilities. Ensures continued compliance to current regulatory requirements (CGMPS), industry standards and corporate policies and procedures
- Maintain oversight of team that reviews and approves GXP Assessments for facilities, utilities, manufacturing equipment, and computerized systems, applications and components to define the collective requirements for validation
- Oversees and participates in the review of technical data generated during validation execution to assure that accurate conclusions. Reviews and approves validation and test reports to adequacy and completeness
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