Senior Project Manager, Sterility Assurance & Capital Projects
Listed on 2026-09-05
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Engineering
Operations Management, Regulatory Compliance Specialist
Senior Project Manager, Sterility Assurance & Capital Projects
Location: Bradley, IL (100% Onsite)
Duration: October 2026 – December 2028
Employment Type: Contract Consultant
Target Pay Rate: $120-$140/hour
Position OverviewWe are seeking an experienced Senior Project Manager to lead a portfolio of engineering, facility, and manufacturing improvement projects supporting sterile pharmaceutical operations. This individual will oversee multiple work streams from project planning through design, execution, commissioning, qualification, and operational readiness.
The ideal candidate will bring extensive experience leading large pharmaceutical capital projects within GMP-regulated environments, including aseptic manufacturing, cleanroom operations, facility modernization, and cross-functional engineering programs.
Key Responsibilities- Lead multiple concurrent capital and engineering projects.
- Direct project teams through planning, design, procurement, construction, commissioning, and qualification.
- Manage project schedules, budgets, risks, and resource allocation.
- Facilitate design reviews and technical decision-making with engineering and operational stakeholders.
- Lead development of project execution plans, user requirements, risk assessments, and supporting project documentation.
- Coordinate activities across Engineering, Quality, Validation, Manufacturing, Facilities, and Operations groups.
- Drive issue resolution and escalation management.
- Ensure compliance with GMP and quality requirements throughout project execution.
- Develop and present executive-level project status updates.
- Manage external engineering firms, contractors, and service providers.
- Bachelor’s degree in Engineering or related technical discipline.
- 15+ years of pharmaceutical or biotechnology experience.
- 10+ years leading large capital projects or engineering programs.
- Experience with in sterile manufacturing or aseptic processing environments.
- Strong background in project engineering and design management.
- Experience supporting commissioning and qualification activities.
- Demonstrated leadership of multidisciplinary technical teams.
- Annex 1 compliance remediation experience.
- Fill-finish manufacturing experience.
- Biologics manufacturing experience.
- Cleanroom facility upgrade experience.
- Sterility assurance initiatives.
- Facility expansion or modernization projects.
- Experience managing projects exceeding $10MM.
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