GMP Capital Projects Lead for Sterile Manufacturing

Proclinical Staffing; Durham (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

Proclinical Staffing is seeking a Senior Project Manager to lead large GMP capital projects within the pharmaceutical manufacturing space, including sterile operations, packaging, and facility growth. This role focuses on driving complex facility expansions and strategic investments to support GMP-compliant manufacturing.

You will lead end-to-end execution across design, procurement, construction, CQV, turnover, and closeout, while managing budgets, schedules, risks, and stakeholder

Qualifications

• Degree in Engineering, Construction Management, Project Management, or a related technical field.
• Experience leading large-scale capital projects in pharmaceutical, biotechnology, or GMP-regulated environments.
• Proven track record of managing multiple capital projects from initiation to completion, valued at approximately $350M.
• Strong knowledge of GMP, cGMP, FDA validation, and regulatory requirements.

Responsibilities

• Lead end-to-end execution of large-scale GMP capital projects, including sterile manufacturing and facility expansion.
• Oversee projects from business case development through design, procurement, construction, CQV, turnover, and closeout.
• Act as the primary engineering and project leadership representative for major capital investment programs.
• Collaborate with cross-functional teams, including Engineering, Manufacturing, Quality, Automation, Procurement, and EHS.
• Develop and manage project scope, budget, schedule, governance, KPIs, and execution strategies. Proactively manage risks, mitigation planning, and resolution of complex project challenges. Supervise external partners, including A-E firms, construction contractors, OEMs, and vendors, to ensure project success.
• Ensure compliance with GMP requirements, site standards, quality expectations, and EHS regulations.
• Communicate project performance, financial status, risks, and milestones to senior leadership.
• Mentor project teams and promote operational excellence through standardized project delivery practices.

Skills

Leadership

Budgeting

Scheduling

Stakeholder communication

Cross-functional collaboration

Education

Engineering / Construction Management / Project Management degree

Job description

Proclinical Staffing is seeking a Senior Project Manager to lead large GMP capital projects within the pharmaceutical manufacturing space, including sterile operations, packaging, and facility growth. This role focuses on driving complex facility expansions and strategic investments to support GMP-compliant manufacturing.

You will lead end-to-end execution across design, procurement, construction, CQV, turnover, and closeout, while managing budgets, schedules, risks, and stakeholder