Process Engineer

Primary Responsibilities

• Design, develop, and optimize bioprocesses for the production of biologics, vaccines, or pharmaceuticals, ensuring scalability, efficiency, and compliance with Good Manufacturing Practices (GMP).

• Analyze process data to enhance yield, quality, and consistency of biopharmaceutical production while minimizing variability and waste.

• Collaborate with cross-functional teams, including R&D, manufacturing, quality control, and regulatory affairs, to implement process improvements and resolve production challenges.

• Develop and maintain standard operating procedures (SOPs), batch records, and process documentation to ensure compliance with FDA, EMA, and other regulatory standards.

• Conduct risk assessments and implement process controls to ensure safety, product quality, and adherence to Current Good Manufacturing Practices (cGMP).

• Lead or support capital projects, including the design, installation, and validation of bioprocessing equipment such as bioreactors, chromatography systems, and filtration units.

• Monitor key performance indicators (KPIs) such as process yield, cycle time, and product purity, generating reports to evaluate performance and guide decision-making.

• Identify and implement cost-saving initiatives through process optimization, media optimization, or resource-efficient technologies.

• Provide technical expertise and training to manufacturing staff to ensure proper execution of bioprocesses and adherence to SOPs and safety protocols.

• Perform root cause analysis and develop corrective and preventive actions (CAPAs) for process deviations or non-conformances.

• Support the development and management of process budgets, aligning with organizational financial and production goals.

• Stay current with industry advancements in bioprocessing technologies, regulatory guidelines, and best practices to drive innovation and continuous improvement.

• Ensure compliance with environmental, health, safety, and regulatory requirements, participating in audits, inspections, and training as needed.

• Perform additional duties as assigned to support biopharma operations and organizational objectives.

Secondary Responsibilities

• Assist in the evaluation, selection, and validation of new bioprocessing equipment or technologies to enhance production capabilities.

• Maintain accurate records of process development, technology transfer, and validation activities to support regulatory submissions and audits.

• Coordinate with vendors and suppliers to source raw materials, consumables, or equipment critical to bioprocesses.

• Provide technical support to other departments, such as quality assurance or supply chain, during high-demand periods or special projects.

• Contribute to technology transfer activities, ensuring seamless scale-up or scale-out of processes from development to commercial production.

• Foster effective communication with cross-functional teams to align on project timelines, process goals, and regulatory requirements.