Manufacturing Engineer II (Process Expert)

Siegfried; Irvine, Northern (CA, KY); Hybrid; USD 105,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Flexible Spending & HSA Options

Life Insurance

Short & Long Term Disability

Pet Insurance

Generous PTO

401K

Job summary

Siegfried is hiring a Manufacturing Engineer II (Process Expert) to support API, formulation, aseptic fill-finish, and packaging operations within a GMP environment. You will drive process optimization, equipment qualification, investigations, and technology transfers across the production spectrum.

The role focuses on owning production instrumentation, IQ/OQ/PQ activities, and writing critical technical documentation while mentoring manufacturing personnel and collaborating across

Qualifications

• Bachelor's degree in Engineering, Biological Sciences, or a related technical discipline.
• 3+ years of experience supporting pharmaceutical, biotechnology, biologics, cell and gene therapy, or CDMO manufacturing operations in a GMP-regulated environment.
• Experience qualifying equipment and manufacturing processes in a regulated manufacturing environment.
• Strong technical writing, data analysis, troubleshooting, and problem-solving skills.
• Working knowledge of GMP regulations, quality systems, and data integrity requirements.
• Demonstrated ability to manage multiple priorities in a fast-paced manufacturing environment.
• Strong communication and collaboration skills with the ability to influence and work effectively across cross-functional teams.

Responsibilities

• Provide technical support for GMP pharmaceutical manufacturing operations.
• Own and maintain critical manufacturing documentation, including SOPs, Master Batch Records, protocols, risk assessments, investigations, and technical reports.
• Lead or support equipment qualification activities (IQ/OQ/PQ), process validations, and continuous improvement projects.
• Serve as the technical owner for production instrumentation, including calibration, preventive maintenance, troubleshooting, requalification, and repair coordination.
• Lead investigations, root cause analyses, and corrective actions related to manufacturing events.
• Partner cross-functionally with Manufacturing, Quality, Engineering, and other stakeholders to ensure efficient, compliant, and reliable operations.
• Support process optimization, implementation of new technologies, and introduction of new products.
• Maintain inspection readiness and ensure compliance with GMP, FDA, safety, and environmental requirements.
• Provide technical guidance and training to manufacturing personnel.
• Support manufacturing operations directly as business needs require.

Skills

Technical writing

Data analysis

Troubleshooting

Problem-solving

Communication

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Biological Sciences

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

Are you a pharmaceutical manufacturing engineer who thrives on solving complex technical challenges, improving processes, and driving operational excellence in a GMP environment? Join our growing CDMO team and play a critical role in supporting the production of therapies that make a meaningful difference in patients' lives. As a Manufacturing Engineer II (Process Expert), you will serve as a key technical resource for production processes and manufacturing instrumentation, driving process optimization, equipment qualification, investigations, technology transfers, and continuous improvement initiatives across API, formulation, aseptic fill-finish, inspection, and packaging operations.

What You'll Do

• Provide technical support for GMP pharmaceutical manufacturing operations.
• Own and maintain critical manufacturing documentation, including SOPs, Master Batch Records, protocols, risk assessments, investigations, and technical reports.
• Lead or support equipment qualification activities (IQ/OQ/PQ), process validations, and continuous improvement projects.
• Serve as the technical owner for production instrumentation, including calibration, preventive maintenance, troubleshooting, requalification, and repair coordination.
• Lead investigations, root cause analyses, and corrective actions related to manufacturing events.
• Partner cross-functionally with Manufacturing, Quality, Engineering, and other stakeholders to ensure efficient, compliant, and reliable operations.
• Support process optimization, implementation of new technologies, and introduction of new products.
• Maintain inspection readiness and ensure compliance with GMP, FDA, safety, and environmental requirements.
• Provide technical guidance and training to manufacturing personnel.
• Support manufacturing operations directly as business needs require.

Qualifications Required

• Bachelor's degree in Engineering, Biological Sciences, or a related technical discipline.
• 3+ years of experience supporting pharmaceutical, biotechnology, biologics, cell and gene therapy, or CDMO manufacturing operations in a GMP-regulated environment.
• Experience qualifying equipment and manufacturing processes in a regulated manufacturing environment.
• Strong technical writing, data analysis, troubleshooting, and problem-solving skills.
• Working knowledge of GMP regulations, quality systems, and data integrity requirements.
• Demonstrated ability to manage multiple priorities in a fast-paced manufacturing environment.
• Strong communication and collaboration skills with the ability to influence and work effectively across cross-functional teams.

Preferred Experience

• Experience with aseptic processing and fill-finish operations, including equipment preparation, formulation, sterile filtration, and filling.
• Experience supporting API manufacturing, sterile manufacturing, or commercial pharmaceutical production.
• Prior aseptic fill-finish experience is preferred and will provide a strong foundation for success in this role due to the cross-functional support provided across sterile manufacturing operations.

Work Environment

Up to 50% of time spent supporting manufacturing operations on the production floor. Ability to safely lift, push, or pull materials and equipment up to 50 pounds, with or without reasonable accommodation. Ability to work in GMP manufacturing environments, including ISO 5 through ISO 8 classified cleanrooms, while wearing required gowning and PPE, including safety glasses, masks, gloves, hair coverings, scrubs, lab coats, and Tyvek suits. This position supports a 24-hour pharmaceutical manufacturing operation and requires close partnership with production teams across manufacturing schedules.

Why Join Us?

This is an opportunity to broaden your expertise across the pharmaceutical manufacturing lifecycle while taking ownership of critical processes, equipment, and improvement initiatives in a growing CDMO environment. You'll gain exposure to API production, aseptic fill-finish manufacturing, process validation, continuous improvement, and cross-functional project leadership, all while contributing to the delivery of therapies that improve patients' lives.

Compensation

Target Salary Range: $105,000 - $120,000. 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
• Generous PTO, Sick & Holiday Time Off
• 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.