Senior Project Engineering Manager (Pharmaceutical - Construction)
Cumming Group · Greater Richmond Region · 1 mo ago
Project Management$121k–$170k/yrFull-time
About the role
At Cumming Group, you will work on some of the world's most exciting projects in a dynamic environment where your success is measured by the impact you make. We are one of the fastest‑growing project and cost management consultancies in the United States, ranked in the top 15 by ENR. With over 70 offices globally, a diverse project portfolio, and double‑digit year‑over‑year revenue growth, the opportunities to make your mark are limitless!
Responsibilities
- Provide owner‑side technical oversight of pharmaceutical facility design and engineering.
- Review concept, basic design, detailed design, vendor, and construction packages for technical and cGMP compliance.
- Confirm user, manufacturing, operational, validation, and regulatory requirements are incorporated into design.
- Review process, mechanical, piping, HVAC, cleanroom, electrical, automation, utility, laboratory, warehouse, and support‑building designs.
- Review process and clean utility systems, including purified water, water for injection where applicable, clean steam, process gases, compressed air, HVAC, and waste systems.
- Evaluate personnel, material, waste, equipment, and product flows.
- Review room classifications, pressure cascades, zoning, containment, environmental conditions, and hygienic design.
- Review equipment layouts, P&IDs, utility requirements, specifications, and control philosophies.
- Coordinate technical interfaces across manufacturing buildings, central utilities, laboratories, tank farms, warehouses, and infrastructure.
- Identify design gaps, technical conflicts, constructability issues, and GMP risks.
- Support HAZOPs, process hazard analyses, design‑risk assessments, and technical change control.
- Confirm designs support commissioning, qualification, cleaning, maintenance, operation, and future expansion.
Skills
- cGMP pharmaceutical facility design and engineering.
- Experience with API, peptide, biologics, monoclonal antibody, bioconjugate, or comparable manufacturing processes.
- Knowledge of process systems, clean utilities, HVAC, cleanrooms, laboratories, automation, and material handling.
- Expertise in contamination control, segregation, containment, hygienic design, and cleanability.
- Proficiency with process flow diagrams, P&IDs, equipment layouts, utility diagrams, control narratives, and engineering specifications.
- Familiarity with FDA and EMA expectations, ISPE guidance, ASME BPE, NFPA, and applicable engineering standards.
- Understanding of CQV, Quality by Design, data integrity, process safety, and operational readiness.
Qualifications
- Bachelor’s degree in Chemical, Mechanical, Process, Biochemical, or Pharmaceutical Engineering.
- 12+ years of pharmaceutical engineering or capital‑project experience.
- 5+ years in a Technical Lead, Engineering Lead, Design Manager, or GMP Lead role.
- Greenfield cGMP design, construction, CQV, and startup experience.
- Professional Engineer registration preferred.
Pay
The salary range for this full‑time role is $121,200.00 – $169,666.69 per year. This reflects base salary only and does not include the total compensation package.
Benefits
- Medical/Dental Insurance
- Vision Insurance
- 401(k) retirement plan
- 401(k) matching contributions
- Paid Time Off
- Paid Holidays
- Short‑ and long‑term disability coverage
- Employee Assistance Program