GMP Compliance Specialist: Change Control, Deviations & CAPA

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 85,000 - 120,000; Full time

Job summary

PCI Pharma Services seeks an Engineering Compliance Specialist in Bedford, NH within the Engineering department under the Director, Engineering and Maintenance. The role focuses on change controls, deviations, CAPA plans, and SOP updates to support sterile fill finish operations.

You will collaborate across quality, manufacturing, and engineering to ensure regulatory compliance, drive continuous improvement, and improve overall equipment and process integrity.

Qualifications

• 2+ years’ experience with GMP, ISO, and/or an FDA-regulated environment.
• Strong technical writing and SME in quality system documents.
• Experience with root cause and risk analysis in a cGMP environment.
• Bachelor’s Degree in a Science or Engineering field preferred.

Responsibilities

• Initiate, review, and manage change control documentation for equipment, processes, and systems.
• Lead investigations into deviations, identify root causes, and implement corrective actions.
• Develop and execute CAPA plans and monitor effectiveness across teams.
• Coordinate cross-functional communication to ensure alignment and timely updates.

Skills

Change control

Deviation handling

CAPA planning

Regulatory compliance

Quality system writing

Education

Bachelor’s Degree in Science or Engineering

Job description

PCI Pharma Services seeks an Engineering Compliance Specialist in Bedford, NH within the Engineering department under the Director, Engineering and Maintenance. The role focuses on change controls, deviations, CAPA plans, and SOP updates to support sterile fill finish operations.

You will collaborate across quality, manufacturing, and engineering to ensure regulatory compliance, drive continuous improvement, and improve overall equipment and process integrity.