Manufacturing Engineer II (Process Expert)

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 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.