IT Validation & Compliance Lead (Onsite)

Role: Lead IT Validation & Compliance expert at a GMP bioproduction facility, ensuring IT solutions meet regulatory standards and support product quality and patient safety. Responsibilities: oversee validation activities for IT infrastructure, systems, and equipment supporting manufacturing and laboratory operations; ensure compliance with regulations like 21 CFR Part 11, EU Annex 11, GAMP; facilitate validation deliverables including URS, DQ, FAT, IQ/OQ/PQ; conduct risk assessments; support audits and inspections; manage change control, deviations, CAPA; lead process improvement initiatives; collaborate with engineering and cross-functional teams; mentor staff; maintain documentation and process adherence. Qualifications: Bachelor’s degree in IT or related field with at least 7 years’ experience in IT compliance within pharma, preferably in API or finished product manufacturing; Master’s preferred with 5+ years’ relevant experience; strong background in validation/testing of IT solutions, GxP, change management; certifications such as COBIT, Lean Six Sigma advantageous; proficient in electronic lifecycle management software (e.g., HP ALM); excellent communication, problem-solving, and project management skills. HighValue: focus on pharmaceutical manufacturing operations, validation, compliance, GxP standards, and audit participation. WorkSetup: Onsite in West Lebanon, NH; minimal travel (~10%).