GMP Design Lead – Pharmaceutical Facility Engineering

Cumming Group; New Site (AL); On-site; USD 115,700 - 161,966; Full time

Benefits offered by this job

Medical

Dental Insurance

Vision Insurance

401(k)

Paid Time Off

Paid Holidays

Disability insurance

Employee Assistance Program

Job summary

Cumming Group is seeking a senior engineering leader to oversee pharmaceutical facility design and capital projects in the United States. You will review design packages for cGMP compliance, supervise process and utility systems, and coordinate interfaces across buildings and laboratories.

The role requires 12+ years of pharma engineering experience, 5+ years in a Technical Lead or GMP Lead role, and a Professional Engineer registration is preferred.

Qualifications

• 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.

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.

Education

Bachelor's degree in Chemical, Mechanical, Process, Biochemical, or Pharmaceutical Engineering

Job description

Cumming Group is seeking a senior engineering leader to oversee pharmaceutical facility design and capital projects in the United States. You will review design packages for cGMP compliance, supervise process and utility systems, and coordinate interfaces across buildings and laboratories.

The role requires 12+ years of pharma engineering experience, 5+ years in a Technical Lead or GMP Lead role, and a Professional Engineer registration is preferred.