6421 - CSV Engineer (Laboratory) / Validation Engineer 2

Location: Summit, NJ 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. 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 elevate risks, gaps, delays, or documentation issues Qualifications 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 Part11 expectations Strong communication skills and ability to work effectively with cross‑functional teams Experience in biotech, pharma, plasma, or manufacturing laboratory environments Prior experience working in client‑facing hybrid/onsite roles This role can be a local/hybrid setup. At minimum, a 50% on‑site presence is required. 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 Supplemental Life, Hospital, Critical Illness and Legal Insurance Health Savings Account 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 Salary Range (US): $65,000 - $105,000 USD Verista is an equal opportunity employer. #J-18808-Ljbffr