Lead IT Validation & Compliance - Lebanon NH

We are searching for an IT Validation & Compliance Lead to provide subject matter expertise in Computer Systems Validation, process improvement, and IT compliance service delivery management across the site. This position ensures that IT solutions are implemented and released to use in compliance with relevant regulations and standards facilitating the seamless transition and handover of projects to service operations with key stakeholders.

If you thrive on ensuring product quality, patient safety, and data integrity in a hands-on environment, this role puts you right at the center of our GMP bioproduction facility in West Lebanon, NH.

As our Computer Systems Validation (CSV) Expert, you won't just keep us compliant—you’ll keep our tech moving forward safely. You will:

• Own the CSV Lifecycle: Lead validation activities across the entire ecosystem—from IT Infrastructure and systems to computerized equipment in Manufacturing, Labs, Warehousing, and Facilities.
• Keep Us Regulatory-Ready: Ensure full compliance with 21 CFR Part 11, EU Annex 11, and GAMP. You'll drive risk assessments, FMEA, and impact analyses to stay ahead of issues.
• Build & Approve Deliverables: Author, review, and approve everything from URS, DQ, FAT, and SAT to IQ, OQ, and PQ protocols, along with O&M instructions.
• Quality & Audits: Serve as the front-line CSV SME during audits and regulatory inspections. Own Quality System activities including Document Management, Change Control, Deviations, and CAPA.
• Collaborate & Hand Over: Work directly with Engineering on validation and requalification programs. Drive the smooth transition of validated IT solutions over to service operations.
• Drive Process Improvement: Apply Lean / cLEAN visual management tools to track performance, eliminate friction in our CSV program, and deliver clear training across the site.

What You Bring

• Education & Experience: Bachelor’s in IT (or related field) + 7 years of IT compliance experience, OR a Master’s + 5 years. Experience in pharma manufacturing (API and/or Finished Production) is required.
• Validation Track Record: At least 5 years dedicated to IT solution validation and testing in a GxP environment.
• Tech & Quality Stack: Hands-on experience with electronic ALM software (HP ALM preferred), plus deep familiarity with ITIL-style Incident, Problem, and Change Management.
• Audit Ready: Direct experience standing up as a CSV SME during regulatory inspections.
• Bonus Points: Lean Six Sigma (Green or Black Belt) or COBIT certifications.