Commissioning Qualification Validation Specialist
Overview
CQVS-3 or CQVS-4 leads CQV efforts at Salas O'Brien focusing on food pharmaceutical biotech industries. Owns cGMP audits gap analysis risk assessments and develops system specifications per GAMP. Executes IQ/OQ/PQ protocols interfaces with OEM CM contractors and end users. Produces trace matrices summary reports and defends validation results.
What You'll Do11
- 1Conduct cGMP Audits Gap Analysis and Risk Impact Assessments as required to scope CQV efforts
- 2Develop system specifications per GAMP and Good Engineering Practices
- 3Create project CQV Master Plans describing scope intent and strategy
- 4Interface with Original Equipment Manufacturers Construction Managers and contractors to develop commissioning protocols
- 5Work with end users to develop and execute validation protocols
- 6Compile and analyze qualification validation data
- 7Generate Trace Matrices linking system requirements to field verifications
- 8Produce Summary Reports summarizing CQV activities
- 9Represent and defend validation outcomes before client auditors and regulators
- 10Lead validation specialists managing project tasks
- 11Perform additional duties as needed
Requirements13
- 1CQVS-3 or CQVS-4 organized analytical and self-motivated with industry knowledge
- 2Experience managing multiple projects simultaneously at administrative and technical levels
- 3Responsibility reporting to Best Practice Lead Department Manager and Project Manager
- 4Ability to work independently and lead teams
- 5Technical aptitude evaluating engineering documents wiring diagrams P&IDs HVAC drawings and architectural layouts
- 6Proficiency configuring portable measuring instruments
- 7Excellent written verbal and presentation skills
- 8Capacity to assess scope manage changes and solve problems
- 9Professional behavior when interacting with customers vendors and trade contractors
- 10Bachelor's degree in scientific technical or engineering discipline with 5-7 years experience in FDA regulated environment
- 11Associate degree or skilled technician/military veteran with 7-10 years experience in FDA or regulated settings
- 12Proficiency in Windows and Microsoft Office applications
- 13Knowledge of field measuring instrumentation and FDA regulations cGMPs and GAMP
Salary Insight
$90 - $100k per year
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