Pharma Facility Design Lead: GMP, CQV Oversight

cumminggroup; United States; On-site; USD 121,000 - 170,000; Full time

Benefits offered by this job

Medical

Dental Insurance

Vision Insurance

401(k)

Paid Time Off

Paid Holidays

Job summary

Cumming Group in the United States is seeking a senior Pharmaceutical Engineering Leader to provide owner-side technical oversight of facility design and commissioning. You will review concept through detailed design, vendor packages, and construction to ensure cGMP compliance.

The role requires validating that user and regulatory requirements are captured, coordinating interfaces across buildings and utilities, and supporting risk analyses, CQV, and change control to enable reliable operation

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 role.
• Greenfield cGMP design, construction, CQV, and startup experience.
• Professional Engineer registration preferred.

Responsibilities

• Provide owner-side technical oversight of facility design and engineering.
• Review design packages for technical and cGMP compliance.
• Ensure requirements are incorporated into design (user, manufacturing, validation, regulatory).
• Review utility systems, HVAC, cleanrooms, and automation designs.
• Coordinate interfaces across buildings and utilities.
• Identify design gaps and GMP risks.
• Support HAZOPs, process hazard analyses, and change control.
• Validate designs for commissioning, qualification, cleaning, and operation.

Skills

cGMP design

Pharma processes

Process systems

Contamination control

P&IDs & specs

Regulatory standards

Quality by Design

Education

Bachelor's in Eng

Experience 12+ years

Leadership experience

CQV startup experience

PE registration

Job description

Cumming Group in the United States is seeking a senior Pharmaceutical Engineering Leader to provide owner-side technical oversight of facility design and commissioning. You will review concept through detailed design, vendor packages, and construction to ensure cGMP compliance.

The role requires validating that user and regulatory requirements are captured, coordinating interfaces across buildings and utilities, and supporting risk analyses, CQV, and change control to enable reliable operation