Senior Validation Engineer
3 weeks ago
Verista is seeking a highly skilled Senior CQV Engineer to join our team. As a key member of our team, you will be responsible for managing multiple projects and clients, driving activities as a client-facing leader, and acting as the point of escalation and issue management on client projects.
Key Responsibilities:
- Design and execute validation plans
- Conduct and document impact and risk assessments
- Verify system drawings and electrical schematics
- Author and execute technical commissioning, qualification, and validation documentation
- Run test scripts and document results
- Maintain clear, detailed records of qualification and validation
- Develop and review testing documentation
- Make recommendations for design or process modification based on test results
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 (2,000gal+)/receivers, Filter Dryers, Centrifuges, Core Dryers, Powder handling systems, clean rooms, support facilities, and tank farms preferred
- 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
Benefits:
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness, and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
Why Choose Verista?
Verista is an equal opportunity employer.
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