CAPEX Project Manager – Greenfield Biotech

Capex Project Manager – Greenfield Biotech

Our client is seeking two highly technical, hands-on CAPEX Project Managers to spearhead the end-to-end execution of a major Greenfield facility. Each project manager will bring deep engineering fluency in formulation, filling, and inspection or assembly and packaging and can roll up their sleeves, challenge technical designs, help support high-performing engineering teams, and rigorously manage a multi-million-dollar capital budget. You will own the project lifecycle from ground-breaking through formulation, aseptic filling, automated inspection, filling, packaging, and clean utilities validation.

Responsibilities:

• Directly manage the design, construction, and commissioning of a blank-slate (Greenfield) manufacturing facility, ensuring compliance with local codes and global cGMP standards.
• Maintain absolute ownership of the capital budget; drive cost-estimation accuracy during Front-End Loading (FEL), track cash flow, manage contingencies, and aggressively mitigate scope creep.
• Actively participate in the field - working with design engineering, conducting site walks, leading safety reviews, and troubleshooting technical bottlenecks alongside contractors and vendors.

Team Building & Resource Leadership:

• Foster a collaborative, high-accountability culture across internal engineering

Technical Engineering & Process Integration:

• Serve as the primary technical anchor for the facility's core production lines, ensuring seamless integration across the entire lifecycle:
• Formulation:
  Multi-component compounding, formulation vessel engineering, and sterile transfer systems optimized for sensitive GLP-1 biologics.
• Aseptic Filling & Inspection:
  High-speed, isolator-based syringe/cartridge filling lines and advanced Automated Visual Inspection (AVI) systems.
• Assembly & Packaging:
  Automated autoinjector/pen device assembly lines, serialization integration, and high-speed secondary cartoning.

Clean Utilities & Infrastructure Design:

• Provide hands-on engineering oversight for the installation and validation of critical Clean Utilities, including Water for Injection (WFI), Purified Water (PW), Clean Steam, and process gases.
• Collaborate on the design of complex HVAC architectures required to maintain Grade A to D cleanroom environments.

Qualifications:

• Minimum 10 years of capital project engineering experience within the biopharmaceutical sector.
• Proven Greenfield Track Record:
  Successful delivery of at least one major Greenfield manufacturing facility expansion from conceptual design through commercial licensure.
• Engineering Fluency:
  Ability to read and critique P&IDs, electrical schematics, automated logic sequences (PLC/SCADA), and equipment layouts. You must be able to challenge vendor assumptions.
• Domain Expertise:
  Direct experience with formulation, filling and inspection or assembly and packaging, preferably in a sterile injectables facility
• Financial & Project Governance:
  Capital cost tracking, project scheduling software, scope management
• Regulatory Knowledge:
  Deep familiarity with FDA/EMA guidelines, Annex 1 regulations, and ASTM E2500 validation methodologies.

Education &

Certifications:

• Bachelor's Degree in Mechanical Engineering, Chemical Engineering, Bioengineering, or a related technical discipline.

Equal Opportunity

Employer:

RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization.