Engineering Compliance Specialist - GMP & CAPA

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); Hybrid; USD 75,000 - 110,000; Full time

Job summary

PCI Pharma Services in Bedford, New Hampshire seeks an Engineering Compliance Specialist to manage change controls, deviations, CAPA plans, and SOP updates in sterile fill finish operations. You will collaborate with engineering, QA, and manufacturing to maintain regulatory compliance and improve efficiency.

Ideal candidates have 2+ years in GMP/ISO/FDA environments, strong technical writing skills, and experience with root cause/risk analysis in cGMP settings.

Qualifications

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

Responsibilities

• Change Control Management: Initiate, review, and manage change control documentation related to equipment, processes, and systems; facilitate cross-functional communication; conduct impact assessments.
• Deviation Handling: Lead investigations into deviations, identifying root causes and implementing corrective and preventive actions; prepare deviation reports.
• CAPA Planning: Develop and execute robust CAPA plans; coordinate with cross-functional teams; monitor CAPA effectiveness.
• Communication and Collaboration: Act as liaison between engineering, quality, manufacturing, and other departments; provide updates on Change Control, Deviations, and CAPA status.

Skills

Technical writing

Root cause analysis

Quality system documentation

Regulatory compliance

Education

Bachelor's degree in science or engineering

Tools

CAPA software

Job description

PCI Pharma Services in Bedford, New Hampshire seeks an Engineering Compliance Specialist to manage change controls, deviations, CAPA plans, and SOP updates in sterile fill finish operations. You will collaborate with engineering, QA, and manufacturing to maintain regulatory compliance and improve efficiency.

Ideal candidates have 2+ years in GMP/ISO/FDA environments, strong technical writing skills, and experience with root cause/risk analysis in cGMP settings.