Technical Design and GMP Lead (Pharmaceutical - Construction)

Cumming Group•Alabama, NY

7d•$115,700 - $161,967•Onsite

About The Position

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, as reflected in our top 10 rankings in ENR. With over 60 offices globally, an extremely diverse project portfolio, and double-digit year-over-year revenue growth, the opportunities to make your mark are limitless!

Requirements

cGMP pharmaceutical facility design and engineering.
API, peptide, biologics, monoclonal antibody, bioconjugate, or comparable manufacturing processes.
Process systems, clean utilities, HVAC, cleanrooms, laboratories, automation, and material handling.
Contamination control, segregation, containment, hygienic design, and cleanability.
Process flow diagrams, P&IDs, equipment layouts, utility diagrams, control narratives, and engineering specifications.
FDA and EMA expectations, ISPE guidance, ASME BPE, NFPA, and applicable engineering standards.
CQV, Quality by Design, data integrity, process safety, and operational readiness.

Nice To Haves

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.

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.