Impactful GMP Project Engineer (CQV/CAPEX, CDMO)

Siegfried AG; Irvine (CA); On-site; USD 125,000 - 135,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Flexible Spending & HSA Options

Life Insurance, Short & Long Term Disb

Pet Insurance

401K

Job summary

Siegfried AG in Irvine, CA is seeking a Project Engineer III to drive capital projects for a growing GMP-regulated manufacturing environment. You will lead from concept through commissioning, validation, and startup across manufacturing, quality, validation, and facilities teams.

The role targets engineers with 4+ years in pharma/biotech manufacturing and CQV experience, including CAPEX project management and cleanroom exposure. This is an on-site position offering growth and impact.

Qualifications

• Bachelor’s degree in engineering (Mechanical, Chemical, Industrial, Pharma, or related).
• 4+ years’ engineering experience in regulated pharma/biotech/device manufacturing.
• 2+ years in Commissioning, Qualification and Validation (CQV).
• Proven CAPEX project management and equipment implementation.
• Strong GMP knowledge and experience with cleanrooms.

Responsibilities

• Lead CAPEX projects including facility expansions and equipment installations.
• Manage projects from concept through commissioning, qualification, validation, and startup.
• Develop project plans, budgets, schedules, and risk mitigation.
• Coordinate contractors, vendors, OEMs, and cross-functional teams.
• Lead CQV activities and CQV documentation (URS, DQ, IQ, OQ, PQ).
• Support product introductions and process improvements.
• Drive continuous improvement and CAPA investigations.
• Ensure GMP, FDA, and internal quality system compliance.

Skills

CAPEX project management

CQV execution

GMP knowledge

Cross-functional collaboration

Education

Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, Pharmaceutical, or related)

Tools

URS/DQ/IQ/OQ/PQ documentation

Job description

Siegfried AG in Irvine, CA is seeking a Project Engineer III to drive capital projects for a growing GMP-regulated manufacturing environment. You will lead from concept through commissioning, validation, and startup across manufacturing, quality, validation, and facilities teams.

The role targets engineers with 4+ years in pharma/biotech manufacturing and CQV experience, including CAPEX project management and cleanroom exposure. This is an on-site position offering growth and impact.