Lead, Pharmaceutical Facility Design & GMP Compliance

Cumming Group; Richmond (VA); 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 an experienced engineering leader to oversee pharmaceutical facility design and capital projects in the United States. You will review complex designs for cGMP compliance, coordinate interfaces across multiple sites, and identify risks to ensure readiness for commissioning and startup. Ideal candidates hold a B.S.

in a related engineering field, 12+ years in pharma engineering, and at least 5+ years in a technical leadership role. 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 Technical Lead, Engineering Lead, Design Manager, or GMP Lead roles.
• 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 cGMP compliance.
• Confirm user, manufacturing, operational, validation, and regulatory requirements are incorporated into design.
• Review process systems, clean utilities, HVAC, cleanrooms, automation, and labs.
• Coordinate interfaces across buildings, utilities, labs, and infrastructure.
• Identify design gaps, conflicts, and GMP risks.
• Support HAZOPs, process hazard analyses, and design-change control.

Skills

cGMP pharmaceutical facility design

API, peptide, biologics

Process systems

Contamination control

P&IDs, equipment layouts

FDA/EMA guidance

CQV, GMP readiness

design review coordination

Education

Bachelor's degree in Chemical/Mechanical/Process/Biochemical/Pharmaceutical Engineering

Professional Engineer registration (preferred)

Job description

Cumming Group is seeking an experienced engineering leader to oversee pharmaceutical facility design and capital projects in the United States. You will review complex designs for cGMP compliance, coordinate interfaces across multiple sites, and identify risks to ensure readiness for commissioning and startup. Ideal candidates hold a B.S.

in a related engineering field, 12+ years in pharma engineering, and at least 5+ years in a technical leadership role. PE registration is preferred.