Senior Project Engineer, GMP Capital Projects (CDMO)

Initial Therapeutics, Inc.; 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 Disability

Pet Insurance

401K

Job summary

Siegfried in Irvine, CA is seeking a Project Engineer III to lead capital projects that expand and upgrade manufacturing capabilities within a GMP-regulated CDMO. You will drive from concept to commissioning, coordinating cross-functional teams and regulatory-compliant CQV activities to ensure successful startups.

The role targets engineers with 4+ years in regulated environments, 2+ years CQV, and a strong CAPEX track record, including vendor relations and cleanroom experience.

Qualifications

• Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, Pharmaceutical, or related discipline).
• 4+ years of engineering experience in regulated manufacturing environments.
• 2+ years of direct CQV experience.
• Proven experience managing CAPEX projects and equipment implementation.
• Strong GMP manufacturing, validation, and quality systems knowledge.
• Experience working in cleanroom environments.

Responsibilities

• Lead CAPEX projects including facility expansions, utility upgrades, equipment installations, and manufacturing process improvements.
• Manage projects from concept through commissioning, qualification, validation, and operational handoff.
• Develop project plans, budgets, schedules, and risk mitigation strategies.
• Coordinate contractors, vendors, OEMs, and cross-functional stakeholders.
• Lead FAT, SAT, and CQV activities, including URS, DQ, IQ, OQ, and PQ documentation.
• Support new product introductions, process optimization, and equipment lifecycle management.
• Drive root cause investigations, CAPAs, and continuous improvement initiatives.
• Ensure compliance with GMP, FDA, and internal quality system requirements.

Skills

CAPEX project management

CQV experience

GMP manufacturing knowledge

Vendor coordination

Cleanroom experience

Education

Bachelor's degree in Engineering

Job description

Siegfried in Irvine, CA is seeking a Project Engineer III to lead capital projects that expand and upgrade manufacturing capabilities within a GMP-regulated CDMO. You will drive from concept to commissioning, coordinating cross-functional teams and regulatory-compliant CQV activities to ensure successful startups.

The role targets engineers with 4+ years in regulated environments, 2+ years CQV, and a strong CAPEX track record, including vendor relations and cleanroom experience.