Project Manager – Pharmaceutical Capital Projects

About the role

Pharmaceutical / Biotech Manufacturing

Tasks

• Establish project charters, execution strategies, governance structures, and project execution plans.
• Manage project scope, budgets, schedules, risks, change control, and stakeholder expectations.
• Lead design development, engineering reviews, and constructability assessments.
• Coordinate multidisciplinary engineering teams, construction contractors, and equipment vendors.
• Define pharmaceutical packaging line requirements, including layout, throughput/OEE, labeling, vision inspection systems, and serialization.
• Manage packaging OEMs through specifications, Factory Acceptance Testing (FAT), installation, and Site Acceptance Testing (SAT).
• Plan equipment installations and shutdowns while minimizing disruption to manufacturing operations.
• Integrate CQV activities into project execution and drive operational readiness, qualification, and final handover.

Requirements

• Bachelor’s degree in Engineering or a related technical field.
• 10+ years of capital project management experience in pharmaceutical or biotech manufacturing.
• Proven experience managing projects from design and construction through commissioning and qualification.
• Direct experience delivering pharmaceutical packaging lines, line modifications, or serialization projects.
• Strong cost, schedule, risk, contractor, and stakeholder management skills.
• Experience managing complex capital projects with Total Installed Cost (TIC) exceeding $30 million.
• Candidates must demonstrate strong, hands-on experience across design

Location

• Cincinnati, Ohio