6421 - CSV Engineer (Laboratory) / Validation Engineer 2

Job Overview

We are seeking an experienced CSV Engineer to support the implementation and validation of ELLA and Synergy Neo2 laboratory instruments. The ideal candidate should have hands-on experience supporting GxP laboratory instrument implementations and be comfortable managing validation activities for both technologies in parallel.

Validation Engineer 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

Job Requirements

• Strong CSV experience in a GxP laboratory or regulated life sciences environment
• Prior experience with laboratory instrument implementation and validation
• Experience with ELLA and Synergy Neo2 strongly preferred
• 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

Company Culture Guidelines & 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

Pay

• National (US) Range: $65,000 - $105,000 USD

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 (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

Application Instructions

To apply for this job, please visit Verista.com