Process Engineer II

Position Summary:

We are seeking a highly motivated Process Engineer II to support the design, implementation, optimization, and scale-up of pharmaceutical manufacturing processes. This role is critical in ensuring that production processes meet quality, safety, and regulatory requirements while achieving operational efficiency. The ideal candidate will have experience in cGMP environments and a solid background in chemical or biochemical process engineering.

Key Responsibilities:

• Design, implement, and optimize processes for drug substance and/or drug product manufacturing.

• Provides technical expertise in aseptic filling and lyophilization by troubleshooting process issues, optimizing performance, and developing robust lyophilization cycles.

• Support tech transfer of new products from R&D to manufacturing.

• Lead or assist in process scale-up, validation, and troubleshooting efforts.

• Author and review documentation such as batch records, protocols (IQ/OQ/PQ), and technical reports.

• Monitor and analyze process performance metrics to identify trends, deviations, and opportunities for improvement.

• Collaborate with cross-functional teams including Quality, Manufacturing, R&D, and Regulatory Affairs.

• Ensure compliance with FDA, EMA, ICH guidelines, and company policies.

• Support investigations (e.g., deviations, CAPAs) and contribute to root cause analysis.

• Provide on-floor engineering support during manufacturing campaigns.

• Evaluate and implement new technologies or equipment to improve process robustness and efficiency.

Qualifications:

• Bachelor's degree in Chemical, Mechanical, or Biomedical Engineering, Pharmaceutical Sciences, or a related field

• Minimum of 5 years of experience in pharmaceutical manufacturing, with strong knowledge of aseptic filling equipment and processes, including vial washers, depyrogenation tunnels, filling machines, and lyophilizers

• Strong understanding of cGMP regulations and pharmaceutical process validation

• Experience with unit operations such as filtration, chromatography, lyophilization, or aseptic processing

• Proficiency in process modeling and statistical analysis tools (e.g., JMP, Minitab)

• Excellent problem-solving, communication, and teamwork skills

• Ability to work in a fast-paced, dynamic environment with minimal supervision