6444 - Lead CQV Engineer / Lead Validation Engineer

Description Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision‑making and are the result of our significant investment in our people and our capabilities. Job Overview We are seeking a Lead Validation Engineer to lead C&Q scope for drug product filling, isolator, and related aseptic manufacturing equipment. This is a specialist role for someone who has qualified vial filling/capping and isolator systems and can manage sterile boundary risk, vendor package questions, SAT/IOQ execution issues, and quality‑facing closeout. Own filler/isolator-related QP/DQ/QRA/data integrity/ERES/configuration/traceability inputs as applicable, plus SAT leveraging, commissioning, IOQ, QSR, blue tag, and PQ readiness where required Coordinate vendor documentation and execution windows for filler/capper, isolator, labeler, inspection equipment, and associated sterile manufacturing systems Support interface with cleanroom/room qualification, environmental monitoring instruments, utilities, automation/IT, operations, MS&T, and quality Manage sterile equipment risks, test exceptions, deviations, punch items, and closeout evidence through final report approval Lead filler/isolator C&Q scope Support VHP/sterile boundary questions if in scope Author/review IOQ/QSR/TM Job Requirements Bachelor’s Degree or equivalent required 10+ years aseptic filling, sterile manufacturing, isolator, or barrier‑system CQV experience Direct vial filler/capper, isolator, inspection/labeling, VHP/decontamination, glove integrity, leak testing, sterile boundary, environmental monitoring, or Annex 1‑aligned experience Strong field execution profile: can coordinate vendor SAT, manage punch items, document discrepancies, support deviations, and drive final qualification reports Comfort working with quality reviewers on sterile manufacturing risks, critical parameters, acceptance criteria, and evidence expectations Strong technical writing and problem‑solving abilities Location This role requires the ability to be on-site, full‑time in Devens, MA. Salary Range (USA) $87,780 - $147,123 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. 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 Equal Opportunity Employer *Verista is an equal opportunity employer. #J-18808-Ljbffr Verista, Inc.