Pharma GMP Design Lead - Technical & Compliance Oversight

CUMMING GROUP; Alabama; On-site; USD 116,000 - 162,000; Full time

Benefits offered by this job

Medical

Dental Insurance

Vision Insurance

401(k)

401(k) Matching

Paid Time Off

Paid Holidays

Short and long-term disability

Employee Assistance Program

Job summary

At Cumming Group, we seek a senior pharmaceutical facilities engineer to provide owner-side technical oversight of complex pharmaceutical facilities, ensuring cGMP compliance across process systems, utilities, and cleanrooms.

You will review P&IDs, layouts, and control narratives, coordinate interfaces between buildings and central utilities, and lead design risk assessments, HAZOPs, and CQV activities with a team of engineers and technicians.

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.

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 and clean utility systems, including purified water, water for injection where applicable, clean steam, process gases, compressed air, HVAC, and waste systems.
• 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 design

Process systems

Clean utilities

HVAC

Cleanrooms

P&IDs

FDA/EMA expectations

Education

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

Tools

ISPE guidance

ASME BPE

NFPA

Job description

At Cumming Group, we seek a senior pharmaceutical facilities engineer to provide owner-side technical oversight of complex pharmaceutical facilities, ensuring cGMP compliance across process systems, utilities, and cleanrooms.

You will review P&IDs, layouts, and control narratives, coordinate interfaces between buildings and central utilities, and lead design risk assessments, HAZOPs, and CQV activities with a team of engineers and technicians.