Capital Projects Manager (Aseptic Manufacturing)

Job Title: Capital Projects Manager (Aseptic Manufacturing)
Location: Michigan (100% onsite initially, hybrid after a few months)
Job Type: Long-term Project
Start Date: ASAP

Job Description:

We are seeking an experienced Capital Projects Manager with a strong background in engineering and aseptic manufacturing to lead high-value capital projects in a cleanroom manufacturing environment. The ideal candidate will have a hands-on approach and a proven track record of successfully executing $100M $150M capital projects, particularly involving filling lines and lyophilization. This role will be 100% onsite initially, with the flexibility for a hybrid schedule after a few months. Travel expenses will be covered when working in a hybrid mode.

Key Responsibilities:

• Lead and manage capital projects ranging from $100M $150M within a cleanroom and aseptic manufacturing environment.

• Oversee project execution from initiation to completion, ensuring scope, budget, and schedule alignment.

• Manage manufacturing lines, filling lines, and lyophilization equipment installation and commissioning.

• Collaborate with cross-functional teams including engineering, validation, quality, and production.

• Ensure compliance with GMP, FDA, and aseptic processing standards.

• Drive progress through hands-on project management, problem-solving, and risk mitigation.

• Work with contractors, vendors, and internal teams to optimize project execution.

• Provide leadership on capital engineering initiatives, ensuring best practices in facility design, equipment installation, and process validation.

Required Qualifications:

• 10 years of experience in capital project management within aseptic or pharmaceutical manufacturing.

• Proven track record of successfully managing $100M $150M projects in a regulated environment.

• Strong background in cleanroom environments, filling lines, and lyophilization.

• Hands-on, execution-focused leader with the ability to drive projects to completion.

• Experience in GMP, FDA, and regulatory compliance within an aseptic manufacturing setting.

• Ability to work onsite 100% initially, with the flexibility for hybrid work after a few months.

• Strong leadership, stakeholder management, and problem-solving skills.

Preferred Qualifications:

• Engineering degree in Mechanical, Chemical, or Industrial Engineering.

• PMP or similar project management certification.

• Experience working in biopharmaceutical, sterile injectables, or vaccine manufacturing.

• Expertise in capital budgeting, procurement, and contractor management.

Why Join?

• Opportunity to lead high-value capital projects in a cutting-edge aseptic manufacturing environment.

• Long-term project with career growth potential.

• Hybrid work flexibility after the initial onsite period, with covered travel expenses.

• Work with a highly skilled engineering and operations team driving manufacturing excellence.

If you are a results-driven Capital Projects Manager with expertise in aseptic manufacturing and large-scale capital projects, we encourage you to apply today!