Sterility Assurance PM – Annex 1 Upgrade (EU)

i-Pharm GxP; Illinois; On-site; USD 120,000 - 180,000; Full time

Job summary

i-Pharm GxP are seeking a Project Manager to lead Sterility Assurance Remediation workstreams at an established sterile facility in Kankakee, Illinois. The role centers on EU GMP Annex 1 compliance, overseeing design, execution and CQV while aligning with GMP requirements.

The PM will own end-to-end SAR activities, coordinate engineering, QA, CQV, CSV and operations, and drive documentation-heavy processes in a fast-paced environment.

Qualifications

• Strong background delivering projects in pharmaceutical manufacturing environments.
• Experience with sterile/aseptic remediation or upgrade programmes (brownfield/live site).
• Working knowledge of EU GMP Annex 1 and contamination control expectations.
• Experience coordinating multi-disciplinary teams (Engineering, QA, CQV/C&Q, CSV, Operations, contractors).
• Able to work in a fast-paced, documentation-heavy environment with clear stakeholder communication.

Responsibilities

• Own and manage assigned SAR project/workstreams from initiation through handover
• Coordinate Engineering, Quality, C&Q, CSV, Manufacturing and external contractors
• Manage project scope, schedule, risks, deliverables and reporting
• Lead/coordinate design reviews and ensure engineering requirements are met
• Review project documentation and drive closure of deliverables
• Support procurement, construction, commissioning and qualification
• Identify/resolve issues, escalate risks as required, and keep stakeholders aligned

Skills

Project management

Cross-functional coordination

GMP compliance

Stakeholder communication

Pharma manufacturing

Job description

i-Pharm GxP are seeking a Project Manager to lead Sterility Assurance Remediation workstreams at an established sterile facility in Kankakee, Illinois. The role centers on EU GMP Annex 1 compliance, overseeing design, execution and CQV while aligning with GMP requirements.

The PM will own end-to-end SAR activities, coordinate engineering, QA, CQV, CSV and operations, and drive documentation-heavy processes in a fast-paced environment.