Pharma CAPEX Project Engineer III – GMP/CQV

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

Benefits offered by this job

Medical, Dental, Vision

401K

HSA Options

Life Insurance

Disability Insurance

Job summary

Siegfried is seeking a Project Engineer III to drive capital projects in a GMP-regulated CDMO environment. You will lead facility expansions, equipment implementations and qualification activities across Manufacturing, Quality, Validation and Facilities teams, delivering critical processes for client programs and therapies.

Ideal candidates have 4+ years in regulated pharma manufacturing, CQV experience, and a track record of CAPEX project delivery with strong cross-functional collaboration.

Qualifications

• Bachelor's degree in Engineering or related discipline.
• 4+ years in regulated manufacturing environments (pharma/biotech/CDMO).
• 2+ years in CQV (Commissioning, Qualification & Validation).
• Experience managing CAPEX projects and equipment implementations.
• Strong GMP, validation and quality systems knowledge.
• Experience in cleanroom environments.

Responsibilities

• Lead CAPEX projects including facility expansions, utility upgrades, equipment installation, and process improvements.
• Manage projects from concept through commissioning, qualification, validation and startup.
• Develop project plans, budgets, schedules and risk mitigation strategies.
• Coordinate contractors, vendors, OEMs and cross-functional stakeholders.
• Lead FAT, SAT and CQV activities with URS, DQ, IQ, OQ and PQ.
• Support new product introductions and process optimization.

Skills

CAPEX project leadership

CQV experience

GMP compliance

Vendor coordination

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

URS/DQ/IQ/OQ/PQ

Job description

Siegfried is seeking a Project Engineer III to drive capital projects in a GMP-regulated CDMO environment. You will lead facility expansions, equipment implementations and qualification activities across Manufacturing, Quality, Validation and Facilities teams, delivering critical processes for client programs and therapies.

Ideal candidates have 4+ years in regulated pharma manufacturing, CQV experience, and a track record of CAPEX project delivery with strong cross-functional collaboration.