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Become A Senior Validation Engineer

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Working As A Senior Validation Engineer

  • Evaluating Information to Determine Compliance with Standards
  • Communicating with Supervisors, Peers, or Subordinates
  • Getting Information
  • Analyzing Data or Information
  • Identifying Objects, Actions, and Events
  • Deal with People

  • $84,015

    Average Salary

What Does A Senior Validation Engineer Do At Lg Electronics USA, Inc.

* Perform validation software testing for telematics devices and infotainment system.
* Analyze validation testing data to determine if the product meets validation requirements.
* Understand technical specifications and be able to develop test scenarios to validate the system based on the technical specification.
* Analyze and understand flow charts to be able to create system level test procedures to perform validation testing.
* Manage and lead issue reporting and communicate software issues to the development team.
* Track open software issues and verify solutions have been implemented in the next software release.
* Maintain and reinforce the test plan database for specification and requirement changes

What Does A Senior Validation Engineer Do At General Motors

* Responsible for the development and execution of robust Manual Transmission validation plans that comprehend vehicle level features and systems that drive cross-functional requirements and integration, including regulatory compliance.
* Leads defining Manual Transmission validation criteria and methods for vehicle level feature/system definition and functionality to meet performance requirements.
* Feature Technical Specifications/System Technical Specifications
* Lead/Create test procedures for all technical requirements.
* Lead/Create test procedures for all manual transmission performance requirements.
* Support System Engineers in defining interface requirements across SMTs and Integration areas.
* Responsible to work with and coordinate validation activities across multiple SMT areas as required by features/system.
* Provides validation subsystems and components expertise to System Engineering Team in order to successfully meet program deliverables.
* Single point contact to help leverage appropriate subsystem/component expertise.
* To collaborate with manual transmission System Engineers in defining requirements and interface across domains; while utilizing Global TIEs in the development of validation methodology and procedures for system requirements.
* Participates in system DFMEA, Verification &Validation plans & Fault Tree Analysis and incorporates findings and learnings into manual transmission LADV plans.
* Drive system failure mode understanding into validation plans with the objective of reducing safety or compliance recalls.
* Feature FMEA- create validation procedures based on failure modes.
* Provide the validation input into the program specific SORs
* Appendices C2, VCRI, System Technical Specification (STS), and Appendix G2.
* Ensure optimized hardware plans in support of program-level manual transmission LADV plans for system-level validation.
* Provide status of System ADV plan executions to Validation EGM and appropriate PVE(s).
* Update Validation Scorecard/PQMS for feature validation.
* Sign-off PVCL for feature level validation.
* Create CLL PRTS for any issues requiring changes to FTS/feature FMEA.
* Perform read across for validation testing.
* Participate in manual transmission system (or features) technical reviews as appropriate.
* Participate in resolution of issues involving interface SMT’s and other subsystems (ex.
* PRTS).
* Mentor SVE and others to grow organization capabilities.
* The policy of General Motors is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual's age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity/expression or veteran status.
* Additionally, General Motors is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including individuals with disabilities.
* If you need a reasonable accommodation to assist with your job search or application for employment, email us at Careers
* Accommodations@GM.com.
* In your email, please include a description of the specific accommodation you are requesting as well as the job title and requisition number of the position for which you are applying.
* Qualifications
* Bachelor’s degree in engineering
* Understanding of writing, debugging, testing and releasing software for automotive embedded systems
* Excellent people skills – All levels of employment and significant cross-cultural
* Self
* Motivated
* Able to work independently effectively
* Strong appetite for Technical leadership in a very diverse, fast-paced product environment
* Excellent organizational and documentation skills
* Knowledge of the Global Vehicle Development Process, specifically Validation ADV deliverables (Including Hardware and Software attributes) and VDP major milestones/Relating definitions
* Ability to work with limited data and make effective decisions always putting customer 1st.
* Willingness to work non-standard hours and do global travel when required
* Understanding of roles and responsibilities of interfacing counterparts primarily in Validation, Design Release, Suppliers & Supplier Quality

What Does A Senior Validation Engineer Do At Teva Pharmaceuticals

* Support all aspects of the Validation Life Cycle from design through operation and improvement as required for all TBU validation functions.
* Responsible for the preparation of site validation documentation such as qualification protocols, validation master plans, risk assessments and periodic reviews.
* Coordinate and execute approved process validation, IQ, OQ and PQ protocols for a new TBU production facility, and GMP/GLP laboratories supporting large molecule testing
* Prepare reports using data from Process Validation, In-process Manufacturing testing In-process QC testing, and Finished Product QC testing
* Prepare reports using IQ, OQ, PQ, and Commissioning monitoring and test data
* Ensure validation testing performed by vendors is complete and accurate, work with vendors for issue resolution and validation deviation reporting.
* Represent validation in multi-disciplinary teams focused on production facility build and laboratory move activities (working with commissioning, validation, and computerized system validation).
* Support the revalidation program.
* Ensure site alignment with corporate standards and cGMP guidelines.
* Upkeep of validation standard operating procedures.
* Authoring and revising procedures within the electronic documentation management system.
* Attends regular/recurring meetings to support the production facility during campaigns.
* Technically independent and maintains up-to-date knowledge of validation standards and regulatory compliance requirements.
* Independently contributes to development of new site validation standards.
* Work independently and/or with subject matter experts (SME) to implement and/optimize key validation and quality initiatives at TBU.
* Work with QA/Manufacturing group members to initiate and implement corrective and preventive actions.
* Provides weekly and/or monthly project status reports to Management
* Represent TBU in regulatory agency inspections as required.
* Support continuous improvement projects and activities.
* Regular reporting to QA and Manufacturing Management via updates and presentations.
* Attend design meetings, and factory acceptance tests at vendor sites.
* Attends meetings to provide validation input for new projects, and attends critical utility/environmental monitoring excursion team meetings.
* Ensures training is up to date, provides training for validation contractors.
* Qualifications

What Does A Senior Validation Engineer Do At EMC

* Help build our internal product around test and software quality.
* Define the quality strategy for a feature and identify the appropriate success metrics.
* Demonstrate effective verbal and written communication skills across multiple teams to obtain test requirements, build a detailed validation plan, and successfully execute according to an agreed upon schedule.
* Provide high fidelity feedback to development teams for identified feature defects.
* Build and integrate API and feature level frameworks and tests.
* Execution of committed test plans developed by yourself or other engineers.
* Contribute to the culture of quality throughout our broader engineering organization.
* Share experiences and skills to aid team members in enhancing their professional skills and career.
* Possess a strong aptitude exploring new technologies and understanding how to apply them to new product releases and in customer facing support scenarios.
* CANDIDATE REQUIRMENTS
* BS in Computer Science or related technical field, and 4+ years industry experience with network protocols, UNIX/Linux systems software development, or related field.
* Experience working on one or more product release cycles.
* Broad understanding of software testing methodologies.
* Ability to participate in code reviews across both feature and test code.
* Programming in Python or C/C
* Experience with similar languages will be considered

What Does A Senior Validation Engineer Do At Shire

* Write, execute, summarize, and lead validation activities in the
* following areas:
* Facilities
* Equipment
* Utilities
* Shipping I Cold Chain
* Environmental Chambers
* Computer Systems / Plant Automation
* Validation Maintenance
* Validation document control and archival program
* Develop and assess the following Quality System elements for
* Validation:
* Quality Risk Management program
* CAPAs
* Change Controls
* Deviations
* Participate and contribute in the design and development of GMP manufacturing equipment validation and controlled temperature unit validation strategy.
* Provide technical input to strategy / philosophy and assessment of engineering changes
* Represent validation during activities and lead validation efforts and manage projects as required.
* Lead technical projects as they pertain to GMP manufacturing equipment and controlled temperature units.
* Represent validation during audits / inspections (including front-facing) for validation technical expertise
* Lead and manage complex validation and technical projects.
* Participate and lead partner audits and regulatory agency inspections for Validation.
* Author and review responses to inspection observations and agency questions.
* Author and review sections of regulatory filings and annual product quality reviews.
* On
* Going:
* Identify opportunities for continuous improvements, deploy best practices, and proactively update validation programs to reflect current regulations and trends

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Senior Validation Engineer Demographics

Gender

Male

70.3%

Female

25.7%

Unknown

4.0%
Ethnicity

White

48.5%

Hispanic or Latino

18.8%

Asian

18.3%

Black or African American

8.8%

Unknown

5.5%
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Languages Spoken

Spanish

65.4%

French

11.5%

Portuguese

3.8%

Chinese

3.8%

Ukrainian

3.8%

Gujarati

3.8%

Hindi

3.8%

Russian

3.8%
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Senior Validation Engineer Education

Schools

University of Pittsburgh -

13.2%

University of Puerto Rico - Mayaguez

11.0%

Drexel University

7.7%

Northeastern University

6.6%

New Jersey Institute of Technology

5.5%

Rochester Institute of Technology

4.4%

East Carolina University

4.4%

University of Houston

4.4%

University of Phoenix

4.4%

University of Arizona

4.4%

University of Washington

4.4%

North Carolina State University

3.3%

Temple University

3.3%

University of California - San Diego

3.3%

San Diego State University

3.3%

University of North Dakota

3.3%

Pennsylvania State University

3.3%

Johns Hopkins University

3.3%

Towson University

3.3%

Texas A&M University

3.3%
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Majors

Electrical Engineering

14.1%

Chemical Engineering

13.8%

Mechanical Engineering

12.4%

Business

7.9%

Biology

7.6%

Chemistry

6.2%

Computer Science

5.5%

Computer Engineering

4.5%

Biochemistry, Biophysics, Molecular Biology

3.4%

Industrial Engineering

3.4%

Computer Information Systems

2.8%

Engineering

2.8%

Engineering And Industrial Management

2.8%

Pharmacy

2.4%

Project Management

2.4%

Biomedical Engineering

2.1%

Physics

1.7%

Management

1.4%

Electrical Engineering Technology

1.4%

Microbiology

1.4%
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Degrees

Bachelors

47.2%

Masters

28.3%

Other

13.3%

Doctorate

5.6%

Certificate

2.7%

Associate

2.1%

Diploma

0.5%

License

0.3%
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Real Senior Validation Engineer Salaries

Job Title Company Location Start Date Salary
Senior Architectural Validation Engineer-Uvm Expert Centaur Technology, Inc. Austin, TX Oct 03, 2016 $175,000
Senior Cleaning Validation Engineer Aumvis Pharmatec LLC Vienna, VA Aug 03, 2016 $150,405
Senior Acoustic Validation Engineer Apple Inc. Cupertino, CA Nov 19, 2015 $150,000 -
$187,200
Senior Validation Engineer PSC Biotech Corporation Irvine, CA Dec 23, 2015 $134,000
SR. Validation Engineer JSMN International, Inc. Jersey City, NJ Nov 18, 2015 $126,422
SR. Validation Engineer Ambiq Micro, Inc. Austin, TX Nov 21, 2016 $121,000
Mems Validation Engineer-Senior Invensense, Inc. San Jose, CA Jan 09, 2016 $120,000
Senior Wireless Validation Engineer General Motors Company Warren, MI Nov 20, 2016 $117,011
SR. Validation Product Engineer Synaptics, Inc. San Jose, CA Jun 22, 2015 $117,000
SR. Validation Engineer Grifols Diagnostic Solutions, Inc. Emeryville, CA Sep 01, 2015 $115,000
Senior Validation Engineer (Cleaning) Validation Technologies, Inc. Brockton, MA Aug 31, 2015 $114,000
Senior Validation Engineer-Pharmaceutical Systems Patel Consultants Corporation Union, NJ Jul 12, 2016 $111,488 -
$120,000
Senior Validation Engineer Alnylam Pharmaceuticals, Inc. Cambridge, MA Sep 05, 2016 $110,000
Senior Telematics Validation Engineer General Motors Company Warren, MI Sep 03, 2016 $107,000
Senior Validation Engineer Techno Pro Solutions, Inc. Rensselaer, NY Jun 05, 2016 $104,350
SR. Validation Engineer Onstar Corporation Warren, MI Jan 29, 2015 $104,000
Senior Validation Engineer Contract Pharmacal Corp. Hauppauge, NY Dec 12, 2016 $101,858
SR. Validation Engineer Illumina, Inc. San Diego, CA Aug 22, 2016 $100,006 -
$120,000
Senior Engineer, Silicon Validation Keyssa Systems, Inc. Campbell, CA Apr 04, 2016 $100,000 -
$120,000
Senior Validation Engineer Patel Consultants Corporation Lexington, MA Aug 22, 2016 $100,000
Senior Customer Validation Engineer Spirent Communications, Inc. San Diego, CA Jul 25, 2016 $99,024 -
$105,000
Senior Validation Engineer B. Braun Medical Inc. Irvine, CA Aug 25, 2015 $91,085
Senior Validation Engineer Patel Consultants Corporation Parsippany-Troy Hills, NJ Sep 26, 2016 $90,000
Senior Validation Engineer Patel Consultants Corporation Pennington, NJ Jun 09, 2016 $90,000
Senior Validation Engineer ESG Automotive Troy, MI Jan 09, 2015 $89,482
Senior Validation Engineer I Shire Human Genetic Therapies (SHGT) Inc. Lexington, MA Jun 30, 2016 $88,941
Senior HW Validation Engineer Marvell Semiconductor, Inc. Santa Clara, CA Aug 24, 2015 $87,607
Senior Validation Engineer EXA Corporation Burlington, MA Nov 09, 2016 $85,000 -
$95,000
Senior Validation Engineer ESG Automotive Troy, MI Oct 11, 2016 $83,499

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Top Skills for A Senior Validation Engineer

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  1. Protocols
  2. Test Plans
  3. Iq/Oq/Pq
You can check out examples of real life uses of top skills on resumes here:
  • Researched area to find local laboratory to process test product and give reported results to attach to completed/executed protocols.
  • Designed, developed and implemented Test Plans using the detailed business requirements document.
  • Prepare and execute IQ/OQ/PQ protocols and technical reports.
  • Developed manufacturing and regulatory strategies in compliance with FDA regulations.
  • Executed validation Protocols and prepared final reports for systems according to company requirements and FDA standards.

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Senior Validation Engineer Videos

Senior Quality Engineer | Regulatory Affairs Manager [bkjrecruiter]

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