Senior Engineer, Validation Resume Sample
Niko Kub
874 Dagmar Overpass,
Houston,
TX
+1 (555) 377 4028
Work Experience
Senior Hardware Validation Engineer
11/2015
-
PRESENT
Chicago, IL
- Reporting to the United States Verification and Validation ( US V&V) Leader for Vertical Axis Washers and Dryers, the Senior Engineer - V&V uses critical thinking and FMEAs to generate V&V plans with the appropriate type and amount of testing
- Ensure the completion of appropriate activities to identify, evaluate and close all potential safety hazards prior to production
- Execute the the V&V plan and facilitate reviews
- Work with the Failure Review Board to resolve issues and document learnings
- Appropriately close the V&V records for the project including the final V&V report
- Generate and execute CQV plans and protocols in accordance with customers’ standards, guidelines, and practices
- Investigate protocol exceptions or deviations and generate reports
Senior Engineer, Validation
12/2011
-
06/2015
Chicago, IL
- Use test and measurement equipment (e.g., KAYE Validators) during protocol execution
- Read and verify facility and equipment drawings (e.g., P&IDs, AF&IDs, etc.)
- Develop Standard Operating Procedures (SOPs), process workflows, User Requirement Specifications, Turnover Packages, and other regulatory support documentation
- Apply engineering knowledge of, and experience with, manufacturing equipment, process equipment, HVAC, utilities, instrumentation, controls, and automation to support clients
- Support, train and provide guidance to validation specialists/engineers in the delivery of services and areas of expertise
- Working with program manager to define product verification and validation plan and drive the execution of V&V activities
- Synchronizing with system integration steps, coordinate the cross-function verification test in iterative style
- Understand system design requirement and write system verification and validation protocol
Senior Computer System Validation Engineer
11/2004
-
09/2011
Boston, MA
- Working with clinical and marketing people, organize internal and external product validation
- Record and track system issues, lead defect review meeting with design owners, drive design issue fixing and closing
- Providing training and coaching to team member for test skills and methodology
- Write reports summarizing results and statistics for all validation projects
- Review the (sub-)system requirements against the intended environment/use
- Review the (sub-)system against the functional requirements to ensure all of these are
- Evaluate that the applied process and the developed system conform with the
- Technical resource in Portland for Common Powertrain Controller programming, functions, diagnostics and troubleshooting
- Responsible for Powertrain feature/function validation in test vehicles
Education
University of Texas at San Antonio
1999 - 2004
Engineer's Degree in Engineering
Professional Skills
- Strong C/C++ skills, experience in low-level drivers development
- Strong UNIX/Linux skills -Experience with Ixia / Spirent , open source Test tools
- Experience with temperature mapping of environmental chambers, autoclave validation and qualification of freezing procedures is strongly desired
- Strong organizational skills required to respond promptly to multiple tasks on-going simultaneously
- Overall experience in validation/test experience
- Overall experience in validation/test experience
- Overall experience in validation/test experience
How to write Senior Engineer, Validation Resume
Senior Engineer, Validation role is responsible for manufacturing, wireless, training, software, reporting, integration, architecture, analysis, design, travel.
To write great resume for senior engineer, validation job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Senior Engineer, Validation Resume
The section contact information is important in your senior 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 Senior Engineer, Validation Resume
The section work experience is an essential part of your senior 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 senior 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 senior engineer, validation position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Senior Engineer, Validation resume experience can include:
- Proven skill in use of thermal mapping equipment in validating, Autoclaves,Tanks, and other temperature controlled units
- Strong problem-solving & analytical skills, creativity and flexibility
- Experience and strong understanding of interaction between SW and HW required
- Experience in a Validation/Quality role in a Biopharmaceutical manufacturing environment
- Strong technical writing skill is required
- Implementing, reviewing and creating validation/verification test cases and test plans, both for DQA and the development teams
Education on a Senior Engineer, Validation Resume
Make sure to make education a priority on your senior 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 senior 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 Senior Engineer, Validation Resume
When listing skills on your senior 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 senior engineer, validation skills:
- Demonstrated ability to work effectively with all levels of organization
- Strong Project Management, organizational, analytical, computer, writing and communication skills
- Cleaning validation experience
- Software Quality assurance experience with Networking protocols including IP/IPv6, UDP, TCP and L4-L7 protocol testing experience
- Validation experience using risk based approach (FMEA, PHA, etc)
- Experience in a Validation/Quality role in a biopharmaceutical manufacturing environment
List of Typical Experience For a Senior Engineer, Validation Resume
1
Experience For Senior Hardware Validation Engineer Resume
- Experience in software/firmware development and validation for constrained embedded systems
- Validate mixed-signal IC to their compliance to standards and specifications
- Develop and document validation plans
- Design, debug, and document validation software
- Experience, 2+ years in a lead role
- Track testing progress and results; assist in managing testing schedule, deliverables and improving team performance
- Coordinate testing of qualification and requalification activities (bio-burden, sterility, residual testing)
- Perform advanced troubleshooting and analysis to understand root cause of Powertrain and vehicle systems and network interaction issues
- Present engineering activity and analysis of failure data to cross-functional organization
2
Experience For Senior Engineer, Product Validation Resume
- Provide NC and CAPA support for NCs involving sterilization issues as needed
- Provide oral and written status reports to management and senior management
- Estimate 5% domestic travel
- Provide prompt and insightful technical assistance to customers, sales partners and IDT staff
- Familiarity with board schematic capture tools and board layout tools is an asset
- Travel overseas to China to support factory builds (estimated 20%)
- Work with the product development teams to isolate failure modes and capture methods to reproduce product problems
- Investigate and resolve protocol exceptions or discrepancies
- Develop technical reports and CQV summary reports
3
Experience For Senior Computer System Validation Engineer Resume
- Develop Standard Operating Procedures (SOPs), process workflows, Validation Master Plans, User Requirement Specifications, Turnover Packages, and other regulatory support documentation
- Perform risk assessments and impact assessments
- Define hardware component qualification schedule and understand business needs with a cross-functional team
- Coordinate execution with a global team and close logistic issues that arise
- Drive execution in hardware component qualification to address PCN, and EOL
- Understand dependencies of component Life Cycle Management against the Nutanix software services
4
Experience For Senior App Validation Engineer Resume
- Engage with vendors for support when necessary
- Identify test coverage gaps and develop test plans to close them
- Knowledge of protocols such as DDR, PCIe, SAS/SATA
- Familiarity with OS/Driver/Component interaction
- Coordination of Sterilization qualification and requalification activities with sterilization vendors. This includes the following routine activities: quarterly dose audits, dose mapping studies following packaging configuration or source changes, and annual EO revelation studies
- Update S-Specifications, and API packaging SOP as a result of the Sterilization qualification and requalification outcomes. Update vendor specifications/paperwork for new components or upon changes to the reference dose range (Gamma only)
- Lead and be a subject matter expert (SME) for API/Component sterilization qualification. Provide guidance to the site as well as R&D for new API and component configurations/materials
- Experience in the following types of validation: Sterilization processes including moist heat, dry heat, gamma, and ethylene oxide
5
Experience For Senior Software Fpag Validation Engineer Resume
- Knowledge of aseptic processing highly desired. Excellent logical/mechanical aptitude desired
- Develop sound scientific rationale/strategy for validation of new or modified cGMP equipment and processes
- Knowledge of cGMP regulations and latest validation guidelines
- Develop RTL test designs, firmware and software to validate transceivers
- Able to work extended/odd hours around manufacturing schedule required
- Design and develop manual and automation test plans and test cases according to requirements
- Evaluate and perform a gap assessment between guidance and regulations and test methodologies when compared to our current sterilization processes
6
Experience For Senior Validation Process Engineer Resume
- Lead test team activities and day-to-day operations of the team as well mentor junior test engineers
- Assist in continuous test process improvement, test automation and regression test cycle reduction
- Track defects discovered and their status, write accurate, detailed test and status reports
- Identify / mitigate risk(s) and escalate project issues (Software, Firmware, Resources) in a timely manner to Project Manager / Team Manager
- Collect and analyze quality metrics and update test documents for release readiness review
- Review test plan and test cases with internal and external team to ensure complete coverage of targeted features and performance expectations
7
Experience For Experience Validation Senior Engineer Resume
- Collaborate and coordinate closely with developers, project managers and other teams to analyze requirements and support development team on defect root cause analysis and provide containment solutions as necessary
- A creative, quick-learner with excellent verbal and written communication skill
- Works well both independently and in a group
- Shows initiative and is highly self-motivated
- Create new memory interface architecture specifications both proprietary and within the standards community such as JEDEC
- Establish hardware and software test environments and infrastructure
- Interface with key industry experts from System OEMS, CPU, DIMM, and DRAM suppliers
8
Experience For Senior Systems Validation Engineer Resume
- Verify ASIC operation against simulation and emulation environments
- Solid experience with laboratory setups to validate and characterize CMOS IC performance in High Frequency (MHz-GHz) domain (spectrum analyzer, VNA, signal source, frequency multiplier, oscilloscope)
- Author risk assessments that identify potential critical process parameters and key operating parameters to prioritize validation activities
- Experience with high frequency application specific circuit elements (mixers, PLL, ADCs, transmission line, waveguide, antenna, etc.)
- Semiconductor experience is desired, preferably in the automotive sector
- Preferably wafer fabrication technology know-how and clean-room experience
- Experience in Verilog/VHDL
9
Experience For Senior HW Validation Engineer Resume
- Demonstrated results managing many projects concurrently
- Previous experience with Qualcomm chipsets
- An understanding of basic unit operations involving cell culture and protein purification is required
- Preferably design know-how of CMOS circuits
- Affinity with product qualification in conformance with the Automotive standards (Q100)
- Support change control activities, deviations and SOP’s for computer systems
10
Experience For Senior FW Hardware Validation Engineer Resume
- Understand Lattice FPGA architecture as well as competitor’s
- Familiarity with Powertrain Mechatronics systems
- Commercial driver’s license Class A
- 6 Month Contract to start
- Experience in 3 or more GMP validation disciplines (Process Equipment, Utility (including HVAC), Laboratory, Automation, Computer Systems, Sterilization, Sterile Filling/Isolator) with advanced technical knowledge
- Knowledge of Validation Lifecycle Approach (URS, FRS, FAT/SAT, Commissioning Protocols, etc) guidelines, international regulatory requirements and standards (GMP, ICH Q7, Q8, Q9, Q10 and other international regulatory requirements
List of Typical Skills For a Senior Engineer, Validation Resume
1
Skills For Senior Hardware Validation Engineer Resume
- Effectively communicate with management and fellow project team members
- Previous experience with validation of complex systems
- Understanding of Good Manufacturing Practices (GMPs)
- Experience in 100Gb, 50Gb, 40Gb, 25Gb, 10Gb, 1Gb Ethernet at a SERDES level including encoding and error correction
- Develop effective protocols using approved tools and processes to accomplish testing plans
2
Skills For Senior Engineer, Product Validation Resume
- Aides in trouble shooting/impact assessment for atypical conditions during sterilization runs/validations
- Experience working with networking protocols
- Review and analyze the validation reports relating to previous applications as
- Strong system level understanding of CPU/SoC architecture, Memories (Flash, RAM)
- Experience with Ethernet auto-negotiation and link training
- Experience in scripting, Python, TCL and Bash
3
Skills For Senior Computer System Validation Engineer Resume
- Experience with lab equipment including Ethernet test equipment, logic analyzer and oscilloscopes
- Experience using high speed lab equipment and the ability to debug complex systems required
- Experience configuring at least one type of Ethernet switch
- Experience with complex programming languages such as C#, C++
- Generate and execute CQV protocols using Good Documentation Practices (GDPs)
- Solid understanding of x86 enterprise architectures, and manageability
- Previous experience with test automation and generating test plans
- Responsible for reporting all ASIC Validation activities and progress to Management
- Temperature mapping experience
4
Skills For Senior App Validation Engineer Resume
- Experience in system engineering
- Experience with wireless networking, in general
- Experience with Cellular wireless and WiFi testing is an asset
- Aseptic processing experience
- Work with different stake-holders on validation strategy, and definition (chip-lead, silicon architect, product manager, etc.)
- Assign tasks to team members, and be the technical focal point for the validation activities
- Monitor validation progress, and support debug activities, to allow root-cause of potential silicon issues
- Be part of the validation team, and own one of the blocks/IPs
- Hands-on experience in lab, and familiar with lab equipment
5
Skills For Senior Software Fpag Validation Engineer Resume
- CQV experience in the life sciences industry
- Self-motivated individual with a proven track record
- Experience in job-related area
- Experience with Vector CANape, CANalyzer and Matlab
- Strong automotive background, hobbies or interests
6
Skills For Senior Validation Process Engineer Resume
- Experience with Ethernet protocols, IP, TCP/UDP, DHCP, DCBX, LLDP
- Advanced knowledge of general verification and validation theories and principles for hardware and software
- Lead project validation test efforts
- Startup equipment in a safe and effective manner
- Experience with embedded Linux, preferably on ARM
- Experience with sensors, audio, power supplies, I2C/SPI/UART buses, and high-speed electrical signal characterization
- Experience in embedded code development
7
Skills For Experience Validation Senior Engineer Resume
- Relevant hardware and lab experience in the Semiconductor industry
- Experience in hardware debug and design
- Experience with audio, power supplies, video, cameras, I2C/SPI/UART buses, and highspeed electrical signal characterization
- Identifying, reporting, and following up on test failures and observed defects
- Understanding new chip features and being able to define test plan to cover it’s functionality
8
Skills For Senior Systems Validation Engineer Resume
- Reviewing and creating new/enhanced product requirements to ensure that the products are testable and meet both written and implied requirements
- Writing and execution/coordination of sterilization protocol testing and the respective final report
- Prototyping the idea within the bench top and system level context, using test chips, microcontrollers, FPGAs and software
- Working knowledge of bioreactors, sanitary equipment, hygienic piping, process instrumentation and controls is required
- Understanding of all the Ethernet layers, PMD/PCS/MAC
- Understanding of all relevant Ethernet specifications, 802.3cd, 802.3by etc
9
Skills For Senior HW Validation Engineer Resume
- Once isolated, working with domain experts to define debugs and come up with a root cause. Assisting in driving a fix
- Clearly document and track defects found during testing cycles in bug tracking system
- Understand multithreading, locks, message passing, scheduler, memory management, interrupts, cache management and typical code execution
- BS/MS in Mechanical, Chemical, Electrical Engineering, Computer Science or equivalent
- BS in Mechanical, Chemical or Electrical Engineering or equivalent
- Proficiency with programming languages such as C, C#, C++, Java, XML and VB
- Support marketing and sales efforts with lab data on next generation products
- System level knowledge of timing platforms and interfaces is an asset
10
Skills For Senior FW Hardware Validation Engineer Resume
- Plan and organize testing solutions around project needs and timelines
- Execute testing protocols within the defined plans
- Produce test reports documenting test results
- Provide status reports to V&V management and project leads detailing issues, risks, mitigations, and results
- Advanced knowledge of general software, electrical, and bio-medical test engineering theory
- Perform all testing as assigned
- Develop CQV planning documents to manage CQV projects
- Collaborate with our support organization and provide engineering focus on their top needs
List of Typical Responsibilities For a Senior Engineer, Validation Resume
1
Responsibilities For Senior Hardware Validation Engineer Resume
- Clear understanding of effective software test design especially as it relates to system level testing of embedded systems
- Demonstrated accomplishments in the development of software and hardware testing processes and programs
- Proficient with MS/Office, demonstrated ability to learn and use software engineering tools and applications in MS Windows and Linux environments
- Large scale project experience
- Your English is fluent and ideally have some good basis of German
- Use test and measurement equipment (e.g., KAYE Validators)
- Working knowledge of Medical Device industry standards
2
Responsibilities For Senior Engineer, Product Validation Resume
- Expertise in process equipment in USP or DSP
- Knowledge of US FDA (21 CFR 210, 211, 810) and EU EMEA regulations
- Knowledge of industry guidance
- Customer Support, in IC Level
- In-depth knowledge in ARM based SoC architecture
3
Responsibilities For Senior Computer System Validation Engineer Resume
- Work under pressure, and Support daily calls with customer
- Hands-on use of oscilloscopes, logic analyzers, VNA, BERTs etc
- Develop GxP system lifecycle documentation including validation plans, User Requirements Specifications, Functional Requirements Specifications, testing protocols (IQ/OQ/PQ), user acceptance testing, traceability matrices, final reports, SOPs, change control documentation, and risk assessment (pFMEA) reports as required
- Assists Validation Manager with the development of company policy regarding validation activities and revalidation requirements, frequency, and responsibilities
- Lead validation activities on medium to large projects. Ensure the quality, accuracy, and completeness of commissioning, qualification, and validation documentation and deliverables
- Creation of validation master plans including process validation and revalidation plans, continued process verification plans, and associated protocol and report templates
4
Responsibilities For Senior App Validation Engineer Resume
- Work with compounding center management to schedule and plan equipment and process qualification workload to meet approved schedules. Coordinate validation activities with other departments
- Multitask and independently prioritize in a fast-paced environment
- Ensure existing practices comply with industry standards
- Stay current with industry qualification trends through FDA, ISPE, PDA and bench marked companies
- Excellent interpersonal, communication, and writing skills, ability to analyze technical issues, define/solve problems, establish project plans, statistically evaluate solutions, and draw valid conclusions
- Expertise in Clean-In-Place and Steam-In-Place theory and techniques is required
5
Responsibilities For Senior Software Fpag Validation Engineer Resume
- Familiarity with distributed control systems and process logic controllers is required
- Adherence to cGMP and GDP is required
- In-depth sensors, and mitigation methodologies
- Expertise with temperature, pressure, and speed measurement
- Negotiate, when necessary, and compromise with other project team representatives to achieve project goals
- Willingness to travel and work at various clients’ locations
6
Responsibilities For Senior Validation Process Engineer Resume
- Proficient with Microsoft Office – Word, Excel, PowerPoint, Project
- Flexibility and willingness to travel and work at various clients’ locations
- Negotiate/compromise with other project team members to achieve project goals
- Listen and respect fellow project team member’s ideas and opinions and work through conflicts or disagreements
- Give a recommendation on the suitability of the (sub-)system for intended use and
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