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 majorSterility Assurance Remediation (SAR)programme at an established sterile manufacturing facility inKankakee, Illinois. This programme is driven byEU GMP Annex 1and focuses on upgrading existing operational areas to strengthen contamination control and maintain ongoing compliant manufacturing operations. We’re looking for an experiencedProject Managerto own assigned SAR workstreams end-to-end, coordinating cross-functional stakeholders and contractors through design, execution and CQV, while ensuring continued alignment toGMP and Annex 1requirements.
Key responsibilities: Own and manage assigned SAR project/workstreams from initiation through handover CoordinateEngineering, Quality, C&Q, CSV, Manufacturingand external contractors Manage projectscope, schedule, risks, deliverablesand reporting Lead/coordinatedesign reviewsand ensure engineering requirements are met Review project documentation and drive closure of deliverables Supportprocurement, construction, commissioning and qualificationactivities Identify/resolve issues, escalate risks as required, and keep stakeholders aligned Experience requiredStrong background delivering projects inpharmaceutical / biotechmanufacturing environments Demonstrable experience withsterile / asepticareas and remediation/upgrade programmes (brownfield / live site) Working knowledge ofEU GMP Annex 1and 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 asHVAC and facility/process improvements, cleanroom/grade changes, pass-throughs, MALs/PALs, dispensing/sampling upgrades, CCIT, PUPSIT, and related sterile assurance upgrades.

Also on the board Same function, level within a rung

Level

Manager

Location

Springfield, IL

Occupation

Project Management Specialists

Industry

Pharmaceutical Preparation Manufacturing

Posted

today

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