Pharma Project Engineering Lead: GMP & CQV Expert

Cumming Management Group, Inc.; Virginia (MN); On-site; USD 121,000 - 170,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

401(k) Matching

Paid Time Off

Paid Holidays

Disability Insurance

Employee Assistance Program

Job summary

Cumming Group seeks an experienced engineering leader to provide owner-side oversight for pharmaceutical facility design and validation. You will review designs to ensure cGMP compliance and coordinate across process systems, utilities, and building interfaces.

Ideal candidates bring deep knowledge of FDA/EMA expectations, CQV, and risk management, with a PE license preferred. The role emphasizes design interfaces, risk review, and readiness for commissioning and startup.

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, 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.

Skills

cGMP design

Process systems

P&IDs

HVAC design

Contamination control

Regulatory knowledge

Quality by Design

Education

Bachelors in Chemical/Mechanical/Process Eng

Professional Engineer registration

Tools

P&IDs

HVAC layouts

Job description

Cumming Group seeks an experienced engineering leader to provide owner-side oversight for pharmaceutical facility design and validation. You will review designs to ensure cGMP compliance and coordinate across process systems, utilities, and building interfaces.

Ideal candidates bring deep knowledge of FDA/EMA expectations, CQV, and risk management, with a PE license preferred. The role emphasizes design interfaces, risk review, and readiness for commissioning and startup.