IT Validation & Compliance Lead (Onsite)

Job title: IT Validation & Compliance Lead (Onsite)

About the Role The IT Validation & Compliance Lead provides subject matter expertise in computer systems validation, process improvement, and IT compliance service delivery across the site. This onsite role ensures IT solutions are implemented and released in compliance with applicable regulations, enabling seamless handover to service operations and supporting governance, continuous improvement, product quality, patient safety, and data integrity at a GMP bioproduction facility in West Lebanon, NH.

What You'll Do

• Serve as a CSV expert involved in all IT validation activities including IT infrastructure, IT systems, and computerized equipment supporting laboratories, manufacturing, and business areas like facilities and warehousing.
• Ensure IT solutions comply with 21 CFR Part 11, EU Annex 11, and GAMP requirements.
• Facilitate, review, approve, and as required develop validation deliverables (URS, DQ, FMEA, risk assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ), and Operating and Maintenance Instructions).
• Conduct risk assessments and impact analyses to identify potential compliance issues and develop mitigation strategies.
• Provide guidance and support to project teams on validation and qualification requirements.
• Continuously monitor and improve documentation and processes to ensure regulatory compliance; identify efficiencies in the CSV program and stay informed of industry regulatory changes.
• Perform assigned Quality Systems activities including Document Management, Change Control, Deviations, and CAPAs; write or revise procedures applicable to CSV activities.
• Collaborate with Engineering to prepare the validation, requalification, and maintenance program.
• Provide CSV service delivery management to facilitate seamless transition and handover of projects to service operations with key stakeholders.
• Maintain system documentation according to standards and regulatory requirements.
• Participate as a CSV SME in audits and inspections and provide required documentation to demonstrate validated state.