Process Engineer

About the Role

Serve as the Engineering subject matter expert for a specific process area (cell culture, harvest, purification, clean-in-place, or clean/facility utilities systems), ensuring systems remain in a qualified state. Act as the technical owner for the system lifecycle, including equipment design and installation, qualification, production support, deviation resolution, maintenance, and decommissioning. Monitor system reliability and performance to ensure operational excellence. Develop, evaluate, and implement engineering solutions to complex technical challenges. Support senior engineers in developing and implementing programs related to system qualification, asset management, project execution, and Good Engineering Practices (GEP).

Key Responsibilities

• Develop engineering deliverables including Process Flow Diagrams (PFDs), Piping & Instrumentation Diagrams (P&IDs), System Specifications, and Functional Specifications.
• Implement system modifications through cGMP change control processes.
• Develop and execute Factory Acceptance Tests (FAT), commissioning protocols, and qualification protocols.
• Develop robust calibration and preventive maintenance strategies.
• Lead investigations into system deviations and implement corrective and preventive actions (CAPAs).
• Stay current with biopharmaceutical industry best practices and emerging technologies.
• May serve as Project Manager on small capital projects (less than $1M).
• Partner with cross-functional teams to successfully execute engineering initiatives.
• Complete required training within established timelines.
• Perform other duties as assigned.

Requirements & Tech Stack

• Bachelor's degree in Engineering is required.
• 0 or more years of engineering or related experience with increasing responsibilities is required.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint) and Microsoft Project is required.
• Ability to work effectively in a fast-paced, team-oriented, cross-functional environment is required.
• Strong planning, prioritization, and organizational skills, including knowing when to escalate issues, are required.

Preferred Qualifications

• Experience working in a pharmaceutical or biotechnology regulated manufacturing environment is strongly preferred.
• A Chemical Engineering degree is preferred.
• Engineer-in-Training (EIT) certification or a Professional Engineer (PE) license is preferred.
• Experience working in an FDA-regulated industry utilizing current Good Manufacturing Practices (cGMP) is strongly preferred.
• Working knowledge of core engineering principles, including fluid mechanics, heat transfer, thermodynamics, and mass transfer, is preferred.
• Familiarity with the operation, support, or design of bioreactors, centrifugation, chromatography, tangential flow filtration (TFF), Clean-in-Place (CIP) systems, autoclaves, clean utilities, or HVAC systems is preferred.
• Basic knowledge of process automation, programmable logic controllers (PLCs), instrumentation, and controls is highly desirable.

Important Considerations

• The position requires a combination of sedentary work and walking throughout the facility.
• May occasionally climb ladders.
• May be required to lift up to 25lbs.
• Requires participation in 24/7 on-call support rotation.
• May occasionally be required to wear personal protective equipment (PPE) and other clean room garments.
• Infrequent travel, may approach 25% during project activities.