Lead IT Validation & Compliance - Lebanon NH

Incendia Partners; West Lebanon (NH); On-site; USD 120,000 - 180,000; Full time

Job summary

Incendia Partners in West Lebanon, NH is seeking an IT Validation & Compliance Lead to provide subject matter expertise in computer systems validation, IT compliance, and service delivery management across the site.

You will own the CSV lifecycle, ensure 21 CFR Part 11, EU Annex 11, and GAMP compliance, and collaborate with Engineering to hand over validated IT solutions to operations.

Qualifications

• Bachelor’s in IT or related field with 7+ years IT compliance experience.
• Master’s in IT preferred with 5+ years in pharma manufacturing.
• Experience validating IT systems in a GxP environment.
• Hands-on with HP ALM and ITIL-style change management.

Responsibilities

• Own the CSV lifecycle across IT infrastructure, systems, and equipment.
• Lead 21 CFR Part 11, Annex 11, and GAMP compliance.
• Author and review URS, DQ, FAT, SAT, IQ, OQ, and PQ protocols.
• Manage Quality System activities: Document Management, CAPA, Change Control.
• Collaborate with Engineering on validation and requalification.
• Apply Lean/kaizen visual tools to improve the CSV program.

Skills

IT compliance

CSV expert

GxP experience

ITIL practices

Lean Six Sigma

COBIT

Education

Bachelor's in IT

Master's in IT

Tools

HP ALM

Job description

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.