Engineering Compliance Specialist – GMP & CAPA

Compliance Officer Jobs; Bedford (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

PCI Pharma Services in Bedford, New Hampshire, seeks an Engineering Compliance Specialist to drive change controls, deviations, CAPA plans, and SOP updates in sterile fill finish operations.

You will collaborate with Quality Assurance, Manufacturing, and other departments to ensure regulatory compliance and continuous improvement. A bachelor’s degree in a science or engineering field is preferred, with 2+ years in GMP/ISO/FDA-regulated settings.

Qualifications

• 2+ years of GMP, ISO, and/or an FDA-regulated environment experience.
• Strong technical writer and SME for Quality system documents (CAPAs, Deviations, Change Controls, SOPs, Reports).
• SME in investigation, root cause, and risk analysis in a cGMP production environment.

Responsibilities

• Initiate, review, and manage change control documentation related to equipment, processes, and systems.
• Lead investigations into deviations, identifying root causes and implementing corrective and preventive actions.
• Develop and execute robust CAPA plans and coordinate with cross-functional teams to implement actions.
• Provide regular updates on change control, deviations, and CAPA status to management and stakeholders.

Skills

GMP experience

ISO experience

FDA-regulated environment

Technical writing

Subject matter expert

Regulatory knowledge

Education

Bachelor's Degree in Science or Engineering

Job description

PCI Pharma Services in Bedford, New Hampshire, seeks an Engineering Compliance Specialist to drive change controls, deviations, CAPA plans, and SOP updates in sterile fill finish operations.

You will collaborate with Quality Assurance, Manufacturing, and other departments to ensure regulatory compliance and continuous improvement. A bachelor’s degree in a science or engineering field is preferred, with 2+ years in GMP/ISO/FDA-regulated settings.