Project Engineer III, Pharmaceutical Manufacturing

Siegfried•Irvine, CA

11d•$125,000 - $135,000•Onsite

About The Position

Bring your pharmaceutical manufacturing expertise to a growing CDMO environment where you'll help drive expansion, innovation, and operational excellence. As a Project Engineer III, you'll lead capital projects supporting manufacturing operations, equipment implementation, facility upgrades, and new product introductions within a GMP-regulated environment. Working closely with Manufacturing, Quality, Validation, and Facilities teams, you'll manage projects from concept through commissioning, qualification, validation, and startup, helping deliver the systems and processes that support critical client programs and life-changing therapies. This role is ideal for engineers with experience in pharmaceutical, biotechnology, or CDMO manufacturing who enjoy solving complex technical challenges, collaborating across functions, and making a visible impact on manufacturing performance, compliance, capacity growth, and ultimately the patients who rely on the products we manufacture.

Requirements

Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, Pharmaceutical, or related discipline).
4+ years of engineering experience in pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
2+ years of direct experience in Commissioning, Qualification, and Validation (CQV).
Proven experience managing CAPEX projects and equipment implementation.
Strong understanding of GMP manufacturing, validation, and quality systems.
Experience working in cleanroom environments.

Nice To Haves

Experience within a CDMO environment.
Experience supporting new product introductions and manufacturing scale-up activities.
Experience working directly with vendors, contractors, and regulatory auditors.

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.