Pharma Construction Engineering Lead – cGMP & CQV

Cumming Group; New Site (AL); On-site; USD 121,000 - 170,000; 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

Cumming Group is seeking a senior engineer to provide owner-side oversight of pharmaceutical facility design and engineering for complex capital projects. You will review conformance to cGMP requirements and coordinate interfaces across utility systems, cleanrooms, and laboratories.

Ideal candidates have 12+ years in pharma engineering, 5+ years in technical leadership roles, and a track record with CQV, startup, and design qualification activities. PE registration is preferred.

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 design packages for technical and cGMP compliance.
• Confirm requirements are incorporated into design across systems, rooms, and utilities.
• Coordinate interfaces across buildings, utilities, laboratories, and infrastructure.
• Identify design gaps, conflicts, and GMP risks.
• Support HAZOPs, process hazard analyses, and design-change control.
• Ensure designs support commissioning, qualification, cleaning, and operation.

Skills

cGMP pharmaceutical facility design

API/biologics manufacturing processes

Process systems, clean utilities, HVAC

Contamination control, hygienic design

Process flow diagrams, P&IDs

FDA/EMA guidance

CQV/engineering readiness

Education

Bachelor’s degree in Chemical/Mechanical/Process/Pharmaceutical Eng

Tools

PDMS/AutoCAD

CFD/PROCESS simulation

Job description

Cumming Group is seeking a senior engineer to provide owner-side oversight of pharmaceutical facility design and engineering for complex capital projects. You will review conformance to cGMP requirements and coordinate interfaces across utility systems, cleanrooms, and laboratories.

Ideal candidates have 12+ years in pharma engineering, 5+ years in technical leadership roles, and a track record with CQV, startup, and design qualification activities. PE registration is preferred.