Job Description

Key Responsibilities:

Process Design & Optimization

Contribute to the design and development of biological production processes and systems. Analyze and optimize process parameters to improve yield, quality, and efficiency. Drive continuous improvement initiatives to enhance process capability and production output.

Commissioning & Qualification (CQ)

Participate in commissioning and qualification of new process equipment and systems. Support FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing) during equipment build-outs. Develop user and functional specifications for process equipment.

Equipment & System Management

Design, install, and commission new production units, including upgrades and modifications. Lead or support troubleshooting of process and equipment issues. Propose and evaluate modifications to improve safety, efficiency, and reliability.

cGMP Compliance & Change Control

Ensure process and equipment modifications comply with cGMP and quality standards. Document and validate all process changes in line with regulatory requirements.

Production Support

Maintain safe, reliable manufacturing systems to meet supply and quality needs. Reduce costs, changeover time, and downtime while increasing productivity and throughput. Provide support to operations teams during production campaigns.

Cross-functional Collaboration

Partner with engineering, manufacturing, quality, and EHS teams to align on goals and resolve issues. Provide technical input and support for process risk assessments and safety reviews.

Other Duties

Perform other tasks assigned by the reporting manager. * Travel as required for project or equipment-related activities.