Engineer, Validation Resume Sample
Orpha Hoppe
736 Brekke Mountains,
New York,
NY
+1 (555) 853 5032
Work Experience
Principal, Validation Engineer
01/2017
-
PRESENT
Philadelphia, PA
- Hands-on experience with validation of silicon IC’s
- Experience in the use of FPGA’s for debugging and evaluating IC’s
- Experience with C/C++ – mandatory
- Experience in Embedded Software development – mandatory
- Excellent written and spoken English communication – mandatory
- Communicate effectively with team members and customers
- Strong C programmer
- Familiarity with computer/system/soc architecture
Computer System Validation Engineer
07/2014
-
07/2016
Dallas, TX
- Manage characterization of analog IPs on specific mask
- Contribute to the definition and set up of new development process in regards of validation activity
- Occasional travel to US and other countries in Europe to train or to be trained
- Create and execute protocols for computerised systems, equipment, process controls, and facilities
- Utilise Good Documentation Practice in a GMP atmosphere while generating protocols and reviewing documents
- Review and generate summary reports for executed protocols
- Create validation schedules, coordinate execution efforts with contractors, laboratory staff, equipment support, and quality assurance staff members
- Work through a Manage/Create and execute protocols for computerised systems, equipment, process controls, and facilities
- Work through a Management of Change system to determine the impact of proposed changes to the qualification status of equipment, software, or facilities
Intern Systems Validation Engineer
02/2011
-
02/2014
Chicago, IL
- Work within a team to coordinate validation efforts for the Vehicle Health Management feature
- Perform integration bench level testing for Vehicle Health Management
- Develop test methods and models to be able to test critical components within the system
- Issue PRTS to document issues
- Validate New 32 bit microcontroller Products based on ARM cores
- Lead the entire validation for new mask
- Membership of the Validation specialist team
- Participation in New Product Development reviews and funnel audits
- Support microchip’s groups on technical support and Failure Analysis
Education
University of Wisconsin-Richland
2006 - 2010
Engineer's Degree in Engineering
Professional Skills
- High level of analytical skills with proven problem-solving ability, and excellent interpersonal skills
- Strong debug skills in digital logic and architecture as exhibited by previous simulation/emulation experience
- Excellent scripting skills on- CAPL/Perl/Python
- Demonstrated understanding of project management skills
- Partner with Production, Engineering, IT, QC and Quality to define the process validation/ packaging validation / cleaning validation interface
- Applies engineering and/or scientific skills to technical processes with support from experienced team members
- Excellent Organizational and Communication Skills (written and verbal)
How to write Engineer, Validation Resume
Engineer, Validation role is responsible for digital, design, analytical, interpersonal, software, programming, assembly, architecture, microsoft, english.
To write great resume for engineer, validation job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Engineer, Validation Resume
The section contact information is important in your engineer, validation 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 Engineer, Validation Resume
The section work experience is an essential part of your engineer, validation 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 engineer, validation responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular engineer, validation position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Engineer, Validation resume experience can include:
- Exercise excellent customer service and communication skills to effectively solve Institute IT related issues and interface with all levels within the company
- Good problem solving skills; action oriented and self motivated
- Strong computer skills (Microsoft Office, Microsoft Project, & AutoCAD)
- Excellent trouble shooting skills and the ability to learn and perform under extreme conditions
- Strong training and documentation skills
- Excellent management, organizational and interpersonal skills
Education on an Engineer, Validation Resume
Make sure to make education a priority on your engineer, validation resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your engineer, validation 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 Engineer, Validation Resume
When listing skills on your engineer, validation 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 engineer, validation skills:
- Related experience Experience (2-4 Years) or demonstrated proficiency with Performance engineering
- Experience as a CSV Engineer for 3-5 years, with particular experience in validation of software tools & testing medical products
- Excellent communication, organization and documentation skills
- Strong interpersonal skills, autonomy and rigor
- Working effectively with Engineering teams (Product Engineering, IC Design, Applications, Development Tools, Marketing) within the New Product Development flow
- Experience in Developing and Documenting Test Procedures for RF/Millimeter Silicon or Product Validation in the 2 to 10 GHz range
List of Typical Experience For an Engineer, Validation Resume
1
Experience For Computer System Validation Engineer Resume
- High level analytical/problem solving skills
- Interface effectively with management personnel in IT, Engineering, Quality, R&D, and other technical disciplines
- Manage a variety of assignments effectively, with minimal guidance
- Have the ability to manage time effectively and achieve results in a timely manner
- Review technical documentation including protocols & summary reports for IOQ / PQ testing, and validation SOPs
- Direct experience working in and/or supervising computer systems compliance activities in a medical device, pharmaceutical or other highly regulated industry
2
Experience For Computer Systems Validation Engineer Resume
- Prioritize and handle numerous projects consisting of varying degrees of complexity
- Experience using / working with stand-along computerized lab systems is required
- Quality or quality support experience dealing with computerised systems
- Comfortable in a fast-paced environment with the ability to adjust to changing priorities
- Provide orientation and training to end-users for all modified new validated systems
- Oversee and manage validation instrument inventory including calibrations
3
Experience For Subsystem Validation Engineer Resume
- Partner on departmental or company-wide projects for computer systems validation including, but not limited to e-records / e- signature compliance
- Create comprehensive subsystem-specific validation plans working with Subsystem Lead Engineers, Design Release Engineers, and System Lead Engineers as needed
- Generate and execute CSV protocols (IQ/OQ/PQ) using Good Documentation Practices (GDPs)
- Creates risk analysis on the content of software releases to prioritize testing
- System engineering and transverse management experience
- Assist Global Validation TIEs and System Engineers in defining requirements and interface across domains
- Understand technical requirements and test procedures for validating to customer expectation
- Create, manage, and document Learning Analysis, Development and Validation (LADV) Sub plan activities & conformance to requirements
- Experience of HPLC systems with associated virtual servers
4
Experience For Reliability / Validation Engineer Resume
- Prepare written validation reports
- Four or more years’ experience in job-related area
- Up to 1 year work experience after graduation
- Participate in technical reviews and meetings (validation meetings, change review board, PDTs, etc.)
- Participate in the software change review with the supplier and software SMEs to provide recommendations for validation
- Provide system level validation plan input as needed
5
Experience For RF Validation Engineer Resume
- Participates in system DFMEA, V&V plans & Fault Tree Analysis and incorporates findings and learning's into validation plans
- Engineering experience
- Validation of complete Transceiver functionality and electrical interfaces
- Execute the validation plan
- RF post silicon validation
- Support Vehicle Validation - Type Approval Activities; Coordinate work with internal and external customers and suppliers
- Experience with DDR memory
- Developing and executing CSV deliverables according to regulatory authorities for GxP computer systems to support commercial and development activities
6
Experience For Power & Signal Distribution Systems Global Validation Technical Integration Engineer Resume
- Designing, debugging of test hardware and software for test systems and reference designs
- Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biotechnology, pharmaceuticals and medical devices
- Working knowledge of scientific and engineering principles related to the bio
- Working with a multi-disciplined team to deliver against a challenging schedule for our patients
- Working knowledge of current regulatory guidelines and standards
- Working knowledge of Vehicle Development Process
- Understanding of Instrument Panel Cluster and Infotainment system
- Ensuring computer system qualification requirements are met in a timely and reliable manner
- Working knowledge of electronic record and signature regulations applied to computer systems
7
Experience For Engineer, Validation & Release Resume
- Working with Field and Quality organizations on Failure analysis or support cases
- Understanding of Radio Transceiver architecture with knowledge of how to test and verify RF System performance
- Areas: Computer systems, operating systems, computer architecture, image processing, memory hierarchies, graphics, compilers, storage Programming and scripting
- Relax during energetic team events (wind-surfing, scuba diving, kayaking, etc.)
- Provide equipment, system and facility qualification guidance and strategy during project planning and development phases
- Document Issues identified during testing
- Software development process, optimization techniques, and debugging/testing methodologies
8
Experience For Validation Engineer Co-op Resume
- Comfortable interfacing with a variety of engineering groups (Design, Verification, Production Test, and Applications)
- Electronic Testing Equipment including Network Analyzers, Spectrum Analyzers, Signal Generators, Power Supplies, etc
- B.S. in computer engineering or other related engineering discipline
- Familiarity with integrated transmitters and receivers, impedance matching, PCB layout, and Python scripting
- Graduate (or equivalent) with qualifications in engineering, computer science, quality assurance, or life sciences
- Desire and interest in continuously learning within the EMC discipline
9
Experience For Infotainment Validation Engineer Resume
- Work closely with PCB board designer and manufacturer to develop engineering high speed PCB Board
- Assess pre-existing GxP computer systems for compliance gaps and recommend solutions
- Pro-actively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices
- Builds and maintains trusting, collaborative relationships and partnerships with internal stakeholders which help accomplish key business objectives
- Conduct System Development Lifecycle, system-specific, and IT-related training to the organization
- Creation and execution of qualification protocols (IOQ / PQ), including identification and resolution of non-conformances/deviations
- Manage contractors performing equipment and system qualifications
- Support the execution of engineering projects
- Ensure personal compliance and support departmental compliance to Corporate Compliance, Human Resources and training requirements
10
Experience For Validation Engineer CSV Resume
- Review and Approve Engineering Work Orders
- Review and approve Sourcing documentation
- Understand technical requirements for the subsystem and the vehicle program as well as program timing
- Complete property requests accurately on all programs for relevant subsystem testing at the applicable milestones
- Identify and document Subsystem non-conformances via issue reporting systems and/or RTC Rational Team Concert (RTC) Change Requests (CR)s
List of Typical Skills For an Engineer, Validation Resume
1
Skills For Computer System Validation Engineer Resume
- Strong time management skills and the ability to work towards a deadline
- Proven industry experience with FDA or EMEA standards and regulations in a process model for software development and computer system validation
- Writing and reviewing validation test plans in compliance with Silicon spec and use cases, create validation suite and build automation of diagnostics
- Computer validation experience in a cGMP manufacturing setting
- Valid driver’s license and good driving record if required to travel to other locations
- Project management skills in a dynamic and multi-tasking environment
- Demonstrated experience in the utilization of problem solving tools and methods
2
Skills For Computer Systems Validation Engineer Resume
- Demonstrated thorough understanding of validation processes and interpretation and application of FDA and cGMP requirements
- Product Engineering or Validation experience
- Product Engineering, Validation or Supplier Quality experience
- Solid MCU development (IDE) experience such (IAR, Keil,…), C-language programming
- Effectively manage projects and tasks to deliver deadlines and commitments
- Support and provide input to Validation Master Plan for process, cleaning and packaging validation
- Liaise with computerised system validation specialists across the GSK network in order to share good practice methods and tools
- Demonstrated ability to organize multiple tasks and to change priorities to meet project deadlines
- Work effectively under time constraints within a team environment
3
Skills For Subsystem Validation Engineer Resume
- Experience with RF Silicon Circuit or Product Validation
- Skills in standard development Tools and Methodologies
- Experience with FDA or EMEA standards and regulations in a process model for software development and computer system validation
- Required in work experience in a Computer System Validation within a regulated environment, Medical Device / Pharmaceuticals
- Experience in software and embedded controller design principles and validation processes
4
Skills For Reliability / Validation Engineer Resume
- Manage all validation aspects as part of project work, or act as lead role if specific validation resource has been brought in on the project
- Fluent English and French language skills and driver license necessary
- Assess and perform process/equipment/systems requalifications to confirm and provide evidence that such systems remain in a validated state
- Understanding of software development process for embedded CPUs and experience in developing and debugging software
- Programming / Code analysis experience in C/C++
- Bring-up & development to meet team goals and resolve problems in a timely, effective and professional manner
- Experience measuring, tuning, optimizing RF and/or analog/mixed-signal IC's
- Interested in writing code close to the hardware, and debugging. Validation mindset: detail-oriented, curious, persistent
5
Skills For RF Validation Engineer Resume
- Desired - experience in managing and/or in performing audits in a regulated environment
- Direct experience working in and/or supervising computer systems compliance activities in a medical device and/or pharmaceutical company
- Board or system level engineering knowledge with a solid understanding of RF concepts
- Provide technical decision making regarding validation strategies and requirements for projects
- Prepare, review, and approve various computer validation documents for CSV projects including the following
- Interaction with various engineering teams (like system, hardware design and design validation, software engineers, test engineering) in test-environment
- Determine the quality of the validation by defining coverage goals and methods for measuring these goals. Enhance the test cases until the goals are met
- Hands on RF transceiver with knowledge on including CPUs, RX, TX, Calibrations, RF measurements, DFT regarding validation & debug
6
Skills For Power & Signal Distribution Systems Global Validation Technical Integration Engineer Resume
- Basic automotive knowledge, basic engineering principals, entire Engineering structure (who does what); validation process
- Formal training in Validation ISPE GAMP 5 and Data Integrity training highly preferential
- Experience in pharmaceutical or biotech manufacturing environment
- Experience/understanding of cGMP Quality Risk Management is desired
- Previous experience in design, manufacturing, and quality
- Experience within the Medical Device or Pharmaceutical Industry supporting the manufacture of Regulated Products
- Strong technical writing and oral communications
- ~ 3 years Embedded Development experience with 32 bit microcontroller systems, ARM Cortex-M0+, Cortex-M4, Cortex-M23
- Strong foundational knowledge of analog/RF circuits, structured software development, and measurement techniques
7
Skills For Engineer, Validation & Release Resume
- Carries out engineering responsibilities using accepted methods and practical experience
- Uses local procedures & templates for respective validation documentation
- A BS or MS in Electrical Engineering, Computer Engineering, or Computer Science and 1+ years work experience
- Experience with image sensor processing hardware pipelines (e.g. raw image processing, cameras, MIPI)
- Experience in automotive subsystem testing
- CSV experience in the life sciences industry
- Experience in job-related area
8
Skills For Validation Engineer Co-op Resume
- Ensure that the site is compliant with required regulations in relation to computerised system validation practices for GxP IT systems
- To perform gap analysis against global computerised system validation policies and identify mitigation plan
- Knowledge of and experience with GMLAN or CAN based communication
- University graduate with at least 3 years of experience in similar role ideaqlly within Healthcare Industry
- Experience in job-related area
- Experience with serial communication protocols such as CAN (or GMLAN), LIN, etc
- Level of role depends on experience and qualifications
- Develop, write and execute validation protocols (IQ/OQ/PPQ, etc.), for equipment, systems, products and processes
- Update and maintain Validation Protocols, SOPs, forms, records to meet cGMPs and regulatory requirements
9
Skills For Infotainment Validation Engineer Resume
- Knowledge of product MVSS and Validation requirements
- Experience in Body systems
- Prepares project based validation documentation for computerized systems
- Supports/Manage compliance of DRs and CAPAs for the validation department
- Required in work experience in a Healthcare device or Life sciences pharmaceutical regulated process mature environment
10
Skills For Validation Engineer CSV Resume
- Experience working in HV environments
- Experienced in using PXI hardware test platforms
- Experienced in design of automated test systems, hardware and software
- Experience with fluid cooled HV products
- Experience with controls type software, Emerson Power Tools Control Software, RS Logix, etc
- Assist in 3rd party assessments of the company’s computer systems validation - Equipment program
- Good knowledge of analog and digital electronics
- Operate RF test equipment like spectrum analyzers, power meters, RF amplifiers, RF Generators etc.
- Good knowledge in FPGA architecture is an added advantage
List of Typical Responsibilities For an Engineer, Validation Resume
1
Responsibilities For Computer System Validation Engineer Resume
- Co-op or project experience with validation of automation, packaging, utilities and/or facilities is desired
- Work with other validation engineers to develop scientific approaches for calibration, equipment qualification and validation techniques
- Function effectively independently, as necessary, and lead others to achieve department goals
- Work with teams to perform investigations and troubleshoot issues related to validation
- Assess change controls for impact to validated computer systems
- Oversee all computer validation efforts as the Project Manager
- Monitor the day-to-day computer systems validation activities
- Work with operational users, IT organizations, Quality Assurance organization, management, and vendors on computer system validation issues
- Supervise computer validation consultants
2
Responsibilities For Computer Systems Validation Engineer Resume
- Follow policies and procedures for computer systems validation
- Advise and consult within DePuy Synthes and with suppliers to facilitate timely and complete resolution to computer systems validation issues
- Lead Validation projects ensuring compliance and deliverable timeline expectations are met
- Assist in 3rd party assessments of the company’s computer systems validation program Education
- Manage Validation Test Status (Hardware & Software)
- Report validation status to Program Teams and other leadership forums
- Collaborate with subsystem team: Design Engineers, Subsystem Lead Engineers, suppliers, Global Validation Engineers on subsystem test procedures
- Execute subsystem procedures completely on Electrical Benches, Electrical Frames or Vehicles prior to applicable milestones
- Review Change Requests (CR)/Decision Notices (DN) for validation impact
3
Responsibilities For Subsystem Validation Engineer Resume
- Participate in Validation Peer Reviews as required
- Manage the execution of Supplier Analysis, Development and Validation (ADV) Plans to ensure on-time completion with excellence
- Execute Commodity Validation Sign-off
- Plan and report metrics for assigned validation projects
- Review all calibration, qualification and validation documentation for accuracy, completeness and compliance to company standards
- Provides input & validation expertise to Technology Transfer & project / area support efforts
4
Responsibilities For Reliability / Validation Engineer Resume
- One to two (1-2) years related experience
- Maintain effective work relationships in a team environment
- Prioritize and manage several tasks
- Learning, Failing, Improving, Controlling
- Understanding of one of more of the following protocols: USB (USB3.0, USB2.0), USB Power Delivery, Ethernet (10/100/1000), Flash Media Standards
- Working knowledge of regulatory requirements in the pharmaceutical industry
- Understanding of Instrument Panel Cluster as a system
- Working knowledge of infotainment systems
5
Responsibilities For RF Validation Engineer Resume
- Facilitating and documenting risk assessments to system requirements (e.g. intended use, functional risk)
- Assist in establishing user requirement specifications (URS) and manage them in the quality system
- Work with design engineers to bring up new chip designs and debug board/system/silicon issues
- Knowledge of durability, mechanical testing, CAE analysis applied to either fluid flow, stress, strain or vibration
- Knowledge of related quality systems such as Change Control; CAPA (including Deviations/OOSs)
- Write technical documents relating to applications and computer systems of complexity
6
Responsibilities For Power & Signal Distribution Systems Global Validation Technical Integration Engineer Resume
- S. or Ph.D in Electrical Engineering
- Debug of diagnostics on various platforms using Spectrum analyzer, Oscilloscopes, Logic Analyzers and similar equipment. Propose work arounds
- Participate in Problem Solving Teams; participate in DFMEA work groups
- Analyzes and interprets resulting data from tests (determines data anomolies); Maintains frequent communication with customers
- BSEE/MSEE / Computer Science / Computer Engineering or similar fields
- Develop CSV/CQV planning documents to manage CQV projects
- Familiarity with typical office applications (particularly Excel)
- Coach, train and impart knowledge via the creation of SOP’s and OCAP’s to the value stream members
- Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps and ensure best data integrity practices are enforced
7
Responsibilities For Engineer, Validation & Release Resume
- Design and generate test & measurement patterns / vectors
- Lead Validation Closed Loop Lessons Learned process and work with PSDS GSSLT and/or Systems Engineering to update GMWs/ Technical Requirements/ VCRIs/ADVP&Rs. Monitor PRTS’s, PAL’s, field performance, etc. for new CLL items
- Participate when required on quality tools, i.e. DFMEA’s/DRBFM’s/DRBTR’s
- Tech transfer (new product introduction)
- Lead the development and management of the system level FMEA. Coordinate with the component development teams to ensure component DFMEA’s are complete, accurate and updated
- Design, implement and execute protocols to validate manufacturing equipment, facilities, utilities in a manufacturing environment following the latest cGMP regulations
8
Responsibilities For Validation Engineer Co-op Resume
- FAT, SAT, IQ and OQ documentation development and execution on Automated Systems in the pharmaceutical industry
- Assist in the development and execution of QMS procedures, ICH Q1 (Stability Protocols / Reports), CFR 21 Part 211, CFR 21 Part 820, ICH Q8, ICH Q9, and ICH Q10
- Candidates need to possess good communication and interpersonal skills, flexibility with tasks and the ability to interact with all levels of management, clients, and vendors
- Travel up to 60% nationally or regionally to support installation and start-up activities, attend Client meetings, Design Group management meetings, company sponsored training and industry related seminars, forums or conventions
- Collaborate and communicate closely with IC design engineers, systems engineers, and application engineers to understand design requirements and customer use cases
9
Responsibilities For Infotainment Validation Engineer Resume
- BS in Electrical or Computer Engineering with 5+ years of experience in related field OR MS in Electrical or Computer Engineering with 3+ years of experience in areas such as pre and/or post-silicon validation, mixed-signal IP block design/validation, audio-related signal processing and algorithm, validation-related automation framework
- Author procedures, investigations, protocols, change controls, etc
- Coordinate and/or perform all CSV
- Provide guidance for CSV activities performed by contract service providers
- Participate in cross-functional Project teams to ensure business needs are met and implemented in compliance with associated predicate rules and governing regulations
10
Responsibilities For Validation Engineer CSV Resume
- Author, review and/or approve Computer System Validation SOPs relating to the System Development Life Cycle (SDLC), 21 CFR Part 11 Regulations, Operation and Maintenance, and system-specific procedures
- Author, review, and/or approve IT-related Standard Operating Procedures (SOP) or system-specific SOPs
- Validate/Implement and/or provide direct IT support for the following applications – OpenLAB, EMS/BMS, Particle Monitoring System, Lyophilizer, BOSCH Line manufacturing control stations Maintenance, MasterControl document/training management systems and all other future quality systems
- Meet with decision makers, systems owners, and end users to define business, financial, and operations
- Perform investigations and implement corrective actions related to CAPAs and deviations
- Read and interpret drawings such as PFDs, P&IDs and electrical schematics
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