What are the responsibilities and job description for the Lead CQV Engineer position at LS Solutions?
Lead CQV Engineer Responsibilities:
- Managing the responsibilities on multiple simultaneous projects and/or clients
- Driving the activities as client facing leader and responsible party
- Act as the defined point of escalation and issue management on client projects
- Designing validation plans
- Designing and executing engineering studies for critical process parameter definition and verification prior to validation
- Verifying system drawings including ability to review and as built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer
- Conducting and documenting impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes
- Fluent in working with equipment OEMs and installation vendors
- Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits
- Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
- Running test scripts and documenting results
- Adherence with project schedule for all assigned activities
- Maintaining clear, detailed records qualification and validation
- Documenting impact and risk assessments as part of a team
- Completing user interface testing, software verification, and complete alarm testing on automated systems
- Developing, reviewing, and executing testing documentation
- Making recommendations for design or process modification based on test results when executing test scripts
- General understanding of capital equipment implementation and process knowledge
- Understanding validation documents, URS, IQ, OQ, PQ
Requirements:
- Demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment)
- Demonstrated experience authoring and executing FAT, SAT, IOQ, CSV Protocols
- Must meet onsite work requirements in Rahway, NJ
- 10 years of demonstrated CQV/CSV experience in GMP regulated environments
- Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
- Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization
- Proven attention to detail and organization in project work
- Capable of working on assigned tasks without mentorship
- GMP and Good Documentation Practice training (may be completed at onboarding)
- Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)
- Basic skills with EXCEL and PowerPoint
- Strong interpersonal skills and clear communication capabilities
