Pharma GMP Design Lead — Technical & CQV Expert

JobRx, Inc.; Montevallo (AL); On-site; USD 115,700 - 161,966; 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 technical lead to oversee pharmaceutical facility design and engineering, ensuring cGMP compliance across process systems, clean utilities, and containment strategies. You will review engineering packages, coordinate interfaces across campuses, and support risk assessments.

Ideal candidates bring 12+ years in pharma engineering, 5+ years in leadership roles, and a PE license is preferred. Base salary reflects a wide range and comprehensive benefits package.

Qualifications

• Bachelor's 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 and review P&IDs, utility diagrams, and control philosophies.
• Coordinate interfaces across buildings, utilities, labs, and infrastructure.
• Identify design gaps, conflicts, and GMP risks.
• Support HAZOPs and design risk assessments.

Skills

cGMP pharmaceutical facility design

API processes

Process systems & clean utilities

Contamination control & hygienicDesign

P&IDs & process diagrams

FDA/EMA expectations

Quality by Design & data integrity

Education

Bachelors in Chemical/Mechanical/Process/Biochemical/Pharmaceutical Engineering

12+ years pharmaceutical engineering/capital-project experience

5+ years Technical Lead/Engineering Lead/GMP Lead

Professional Engineer registration (preferred)

Tools

Engineering standards compliance

Job description

Cumming Group is seeking a senior technical lead to oversee pharmaceutical facility design and engineering, ensuring cGMP compliance across process systems, clean utilities, and containment strategies. You will review engineering packages, coordinate interfaces across campuses, and support risk assessments.

Ideal candidates bring 12+ years in pharma engineering, 5+ years in leadership roles, and a PE license is preferred. Base salary reflects a wide range and comprehensive benefits package.