Manufacturing Engineer II; Process Expert

"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.

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.

• 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.

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.

• 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.

• 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 clean rooms
  , 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…