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Project Manager – Capital Projects & Packaging Operations

biotalentColumbus, OHManager L7
BioTalent is partnering with a leading global pharmaceutical manufacturer to recruit an experienced Senior Project Manager to lead high-value capital projects within a GMP manufacturing environment. This position will play a critical role in delivering large-scale packaging and manufacturing investments, overseeing projects from concept and design through construction, commissioning, qualification, and operational handover. The successful candidate will have a proven track record managing complex pharmaceutical capital projects and working across engineering, construction, CQV, and operations teams.
Key Responsibilities: Lead capital projects from initial concept through design, construction, commissioning, qualification, and operational handover. Establish project governance, execution strategies, project charters, and stakeholder engagement plans. Manage project scope, budget, schedule, risks, and change control processes against approved baselines. Provide regular updates to senior leadership and steering committees, including project forecasts and variance analysis. Drive design development activities, design reviews, constructability assessments, and technical decision-making. Coordinate multidisciplinary teams including engineering consultants, construction contractors, equipment vendors, CQV teams, and operations stakeholders. Define packaging requirements including: Throughput and OEE targets Vision inspection systems Labelling and serialization requirements Manage packaging equipment suppliers through specification development, FAT, installation, commissioning, and SAT activities. Develop installation and shutdown strategies to minimize impact on ongoing manufacturing operations. Ensure compliance with GMP standards and support operational readiness planning and successful project handover.
Required Experience: Bachelor's Degree in Engineering or a related technical discipline. 10+ years of project management experience delivering capital projects within pharmaceutical, biotech, or highly regulated manufacturing environments. Demonstrated experience managing projects through design, construction, commissioning, qualification, and start-up. Packaging line installations Packaging line expansions or modifications Proven ability to manage project budgets, schedules, stakeholders, and cross-functional teams. Experience leading capital projects with a Total Installed Cost (TIC) exceeding $30M. Exceptional communication, leadership, and stakeholder management skills. Preferred ExperiencePMP certification. Knowledge of GMP regulations and validation requirements. Experience working within active pharmaceutical manufacturing facilities. Exposure to CQV, equipment qualification, and operational readiness programs.
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Level

Manager L7

Location

Columbus, OH

Occupation

Project Management Specialists

Industry

Pharmaceutical Preparation Manufacturing

Posted

today

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