Process Engineer

We are seeking a motivated and talented Process Engineer to join our team in developing and manufacturing lifesaving sterile drug products such as pre-filled syringes, vials, cartridges and autoinjectors. The Process Engineer plays a critical role in designing, scaling up, and optimizing manufacturing, labeling, and packaging processes in compliance with current Good Manufacturing Practices (cGMP).

The Process Engineer will work with advanced equipment including automated/robotic fillers, filtration and purification systems, sterilizers, isolators, and supporting utilities such as HVAC, steam, compressed air, and USP-quality water systems. The role also involves troubleshooting, process improvement, and collaboration with vendors and cross-functional teams.

Responsibilities:

• Design facilities, process equipment, and utilities to support next-generation medicinal products and technologies.
• Attend review meetings; review and approve user requirement specifications, design specifications, functional specifications, and qualification protocols.
• Attend Factory Acceptance Tests (FAT) to ensure equipment and machinery perform as expected.
• Support formulation, manufacturing, filtration, sampling, and in-process testing of sterile drug products using advanced equipment and instruments.
• Set up, operate, and validate sterile fill robots, automation systems, and software.
• Operate, maintain, and validate mixing equipment such as magnetic drive mixers.
• Collaborate with formulation scientists on drug development and experimental design.
• Define and control critical process parameters to ensure consistent product quality.
• Develop manufacturing processes to eliminate contamination and ensure product safety.
• Operate and validate steam sterilizers and perform sterilization qualification studies.
• Prepare and review regulatory submissions (NDAs/ANDAs and CMC Module 3).
• Design and validate terminal sterilization processes.
• Ensure all critical activities comply with SOPs, protocols, and regulatory standards.

Qualifications:

• Bachelor’s degree in Chemical Engineering, Pharmaceutical Engineering, or Pharmacy with an engineering background.
• Strong verbal and written communication skills with attention to detail.
• Ability to work independently and collaboratively in a team-oriented environment.
• Skilled in troubleshooting equipment and performing complex system tests.
• Familiarity with automation, motion control, pneumatics, and reading P&IDs and schematics.
• Willingness to work in a GMP manufacturing environment, including aseptic cleanrooms and shift operations.
• Eagerness to learn and adapt to new technologies and workflows.

Job Type: Full-time

Pay: From $50,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Employee assistance program
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person