6421 - CSV Engineer (Laboratory) / Validation Engineer 2

Verista • Summit, NJ

5d • Hybrid

About The Position

Verista is seeking an experienced CSV Engineer to support the implementation and validation of ELLA and Synergy Neo2 laboratory instruments. The ideal candidate will have hands-on experience supporting GxP laboratory instrument implementations and be comfortable managing validation activities for both technologies in parallel. This role is crucial for ensuring compliance and successful integration of new laboratory equipment within a regulated life science environment.

Requirements

• Strong CSV experience in a GxP laboratory or regulated life sciences environment
• Prior experience with laboratory instrument implementation and validation
• Ability to manage multiple validation activities or technologies concurrently
• Familiarity with IQ/OQ/PQ, CSV lifecycle documentation, risk-based validation, data integrity, and Part 11 expectations
• Strong communication skills and ability to work effectively with cross-functional teams
• Experience supporting ECQ or lab equipment qualification
• Experience in biotech, pharma, plasma, or manufacturing laboratory environments
• Prior experience working in client-facing hybrid/onsite roles

Nice To Haves

• Experience with ELLA and Synergy Neo2 strongly preferred

Responsibilities

• Support CSV activities for ELLA and Synergy Neo2 instrument implementation
• Develop, review, and/or execute validation deliverables including validation plans, risk assessments, test protocols, traceability matrices, summary reports, and related documentation
• Partner with laboratory, Quality, IT, and project stakeholders to ensure validation activities are completed on schedule
• Support GxP compliance, data integrity, and 21 CFR Part 11 considerations as applicable
• Manage validation workstreams for both instruments simultaneously
• Identify and escalate risks, gaps, delays, or documentation issues
• Support deviation resolution and documentation updates during protocol execution

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed