Process Validation and Commissioning Expert
7 days ago
Verista is a renowned life sciences company that empowers growth and innovation within the scientific community. Our team of 600 experts collaborates with world-class brands to solve complex business needs, focusing on informed decision-making and driving meaningful change in healthcare.
We thrive in a team environment, sharing our mission to enable life sciences clients to improve lives. Our talented professionals are committed to making an impact every day, fueled by a culture that supports our colleagues, prioritizes client success, and promotes inclusivity.
Our Culture Values:
- We empower and support our colleagues
- We commit to client success at every turn
- We have the courage to do the right thing
- We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
- We constantly acquire new skills and learn from our experiences to enhance our collective expertise
This position plays a crucial role in managing multiple projects and clients simultaneously, acting as the primary point of escalation and issue management for client projects. The ideal candidate will possess excellent communication skills, attention to detail, and the ability to work effectively in a fast-paced environment.
Responsibilities:
- Managing responsibilities across multiple simultaneous projects and/or clients
- Driving activities as a client-facing leader and responsible party
- Acting 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 reviewing and as-built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings, as well as verifying electrical schematics with the 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 the 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 of 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
- Specific experience with 6 reactors (2,000 gal+), receivers, Filter Dryers, Centrifuges, Core Dryers, Powder handling systems, clean rooms, support facilities, and tank farms preferred
- Must be willing to work onsite in Germantown, WI
- 5-7 years of demonstrated CQV experience in GMP regulated environments
- Obvious business maturity and interpersonal skills 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
Salary Range:$107,800 - $129,826
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