Project Manager

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

Title: Project Manager – Sterility Assurance Remediation (EU Annex 1)

Location: Kankakee, IL (site-based)

Sector: Pharmaceutical / Sterile Manufacturing

Type: Contract (SAR programme)

i-Pharm GxP are supporting a global pharmaceutical manufacturer on a major Sterility Assurance Remediation (SAR) programme at an established sterile manufacturing facility in Kankakee, Illinois. This programme is driven by EU GMP Annex 1 and focuses on upgrading existing operational areas to strengthen contamination control and maintain ongoing compliant manufacturing operations.

We’re looking for an experienced Project Manager to own assigned SAR workstreams end-to-end, coordinating cross-functional stakeholders and contractors through design, execution and CQV, while ensuring continued alignment to GMP and Annex 1 requirements.

Key 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 activities
• Identify/resolve issues, **escalate** risks as required, and keep stakeholders aligned

Experience required

• Strong background delivering projects in pharmaceutical / biotech manufacturing environments
• Demonstrable experience with sterile / aseptic areas and remediation/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)
• Comfortable in a fast-paced, documentation-heavy environment with clear stakeholder communication

Projects may include areas such as HVAC and facility/process improvements, cleanroom/grade changes, pass-throughs, MALs/PALs, dispensing/sampling upgrades, CCIT, PUPSIT, and related sterile assurance upgrades.