ipharm gxpSpringfield, IL
Project Manager
Project Manager
Project Manager
ipharm gxpSpringfield, IL
today
Pharmaceutical Preparation ManufacturingBiological Product (except Diagnostic) ManufacturingIndustrial Building Construction
Apply for this role →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