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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

  • $101,868

    Average Salary

What Does A Senior Validation Engineer Do At Amgen

* Complete understanding of validation operating standards and procedures
* Lead validation program and support the execution of projects, investigations, and/or troubleshooting.
* Support the development of the validation execution strategy with project teams for Computer, Equipment and Cleaning Validation
* Responsible for interactions with Amgen's Corporate Validation network, offer advice on strategic management of the validation program and present their work during audits and regulatory inspections.
* Structure engineering/characterization studies that integrate cross-disciplinary and cross-functional issues to arrive at optimal course of action
* Establish networks and act as the liaison between corporate and site initiatives along with leading benchmarking activities and continuous improvement efforts
* Responsible for Good Documentation Practices
* Participate and help lead cross-functional teams

What Does A Senior Validation Engineer Do At Pfizer

* Support the validation/qualification of manufacturing equipment, facility and critical utility systems.
* Support validation/qualification of product, cleaning, shipping, aseptic processing (media fill), and sterilization (steam) cycles
* Support the validation/qualification of laboratory equipment
* Develop/Author and execution of FRSs, URSs, FATs, SATs, DQ, IQ, OQ, PQ and other relevant validation life cycle documents
* Develop/Author validation master plans, SOPs, programs and policies, system impact assessments, risk assessments and validation/qualification protocols (facility, equipment, process, product, change/modifications) and periodic requalification
* Work cross functionally with multiple departments to schedule and complete all required activities
* Support corrective actions including investigating and resolving deviations as relevant to validation
* Support technical training on process and technology as required by the project
* Support audit preparation and defend areas of Validation responsibility
* Carryout process capability analysis on all commercial processes on a periodic basis.
* Identify areas for improvement where process capability is deemed to be unacceptable
* Support for preparation and review of the relevant sections of the Annual Product Quality Reports (APQR)
* Review site change controls to ensure the validated state of a process is not impacted by a proposed change
* Lead the implementation of projects to reduce process risk, optimize plant and process productivity
* Will required qualification in Aseptic Gowning and Techniques for cleanroom environments (Grade A through Grade D)
* Role will require after hour and weekend support from time to time

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

* Perform validation software testing for telematics devices and infotainment systems.
* 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

* Create training documentation to support Global Validation Team
* Define, implement and document training plan for new hire resources
* Ensure that training documentation is kept current and readily accessible to the team
* Manage accounts needed for testing; ensure they are active and available to the team to leverage during testing cycles
* Document and maintain test accounts in a central repository
* Create test cases as needed for new/updated features within Mobile Application
* Execute test cases and appropriately document test case results in the defect tracking tool
* Provide SME support QA analysts during test case execution
* Technical knowledge of end-to-end system components of Mobile Application and how the components integrate
* Flexible and able to work in an agile environment
* Manage all new test case creation activities including peer reviews and ensuring test cases are completed prior to the start of testing cycle
* Provide a written and verbal daily testing status report communicating out the overall testing status for a specific release and cycle
* years of mobile testing experience
* Bachelor’s degree in Engineering, IT or related field or 5
* years of real work experience
* Demonstrated leadership skills
* Strong background with testing tools (ALM, JIRA, Rational QM, MSOffice Suite)
* Ability to travel internationally to support global efforts as needed
* Demonstrated knowledge of test case authoring
* Ability to communicate effectively at all levels of the organization

What Does A Senior Validation Engineer Do At Shire

* Write, execute, summarize validation activities in the following areas:
* Computer Systems
* Plant Automation
* Validation Maintenance
* Validation document control and archival program
* Tech Transfer
* Develop and assess the following Quality System elements for Validation:
* Quality Risk Management program
* CAPAs
* Change Controls
* Deviations
* GMP Investigations
* Participate and contribute in design, development, validation strategy, and routine GMP activities:
* Provide technical input to strategy/philosophy for validation activities
* Represent validation during tech transfer activities as required.
* Represent validation during site GMP activities and participate on cross-functional teams
* Varies, 10
* Participate in partner audits and regulatory agency inspections for Validation.
* Author and review sections of regulatory filings and annual product quality reviews.
* Train other Shire staff on validation equipment and protocols
* Ongoing:
* Identify opportunities for continuous improvements, participate in the deployment of best practices, pro-actively update validation programs to reflect current regulations and trends

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Senior Validation Engineer jobs

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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
Senior Process Validation Engineer Respironics, Inc. (A Philips Owned Company) Carlsbad, CA Sep 19, 2015 $120,905
SR. Firmware Validation Engineer Synaptics, Inc. San Jose, CA Oct 12, 2015 $120,000
SR. Firmware Validation Engineer Synaptics, Inc. San Jose, CA Sep 28, 2015 $120,000
Senior Wireless Validation Engineer General Motors Company Warren, MI Nov 20, 2016 $117,011
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 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 Test & Validation Engineer Hyundai Autoever Telematics America Inc. Fountain Valley, CA Nov 18, 2016 $103,444
Senior Validation Engineer Contract Pharmacal Corp. Hauppauge, NY Dec 12, 2016 $101,858
SR. Process Validation Engineer Respironics, Inc. Carlsbad, CA Nov 19, 2015 $100,238
SR. Validation Engineer Illumina, Inc. San Diego, CA Aug 22, 2016 $100,006 -
$120,000
Senior Verification and Validation Engineer Beckman Coulter, Inc. Chaska, MN Feb 22, 2016 $100,000
Senior Verification & Validation Engineer Beckman Coulter, Inc. Chaska, MN May 25, 2015 $100,000
SR. Validation Engineer I Global Pharmatek, LLC Piscataway, NJ Sep 06, 2016 $92,000
SR. Validation Engineer I Global Pharmatek, LLC Piscataway, NJ Jul 07, 2016 $92,000
Senior Validation Engineer B. Braun Medical Inc. Irvine, CA Aug 25, 2015 $91,085
Senior Validation Engineer Patel Consultants Corporation Pennington, NJ Jun 09, 2016 $90,000
Senior Validation Engineer Patel Consultants Corporation Parsippany-Troy Hills, NJ Sep 26, 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

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Top Skills for A Senior Validation Engineer

ValidationProtocolsEnsureComplianceTestProceduresFDAIq/Oq/PqFacilitySummaryReportsTestPlansRegulatoryProcessValidationValidationActivitiesValidationMasterPlanCFRPartRiskAssessmentValidationDocumentationCapaTraceabilityMatrixTestCasesHvacTemperature

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Top Senior Validation Engineer Skills

  1. Validation Protocols
  2. Ensure Compliance
  3. Test Procedures
You can check out examples of real life uses of top skills on resumes here:
  • Review validation protocols for equipment, developed protocols for equipment qualifications.
  • Author validation plans and protocols to ensure compliance with regulatory standards.
  • Support manufacturing by developing manufacturing test procedures.
  • Develop validation policies and procedures for pharmaceutical company as part of the remediation process resulting from the FDA audit.
  • Created and Reviewed Test Plans, Functional Specifications, Design Documents, IQ/OQ/PQ Test script protocols.

Top Senior Validation Engineer Employers

Senior Validation Engineer Videos

Senior Quality Engineer | Regulatory Affairs Manager [bkjrecruiter]

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