Project Engineer III, Pharmaceutical Manufacturing

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

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions - offering long-term opportunities to grow and make an impact.

Your Role:

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.

Your Profile:

Key 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.

Required Qualifications

• 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.

Preferred Qualifications

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

Target Salary Range: $125,000 - $135,000

Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.

Your Benefits:

• Medical, Dental, Vision
• Flexible Spending & HSA Options
• Life Insurance, Short & Long Term Disability
• Pet Insurance
• 401K

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.