Manufacturing Engineer

The Manufacturing Engineer position performs a wide variety of technical duties to support GMP manufacturing operations.

• Transfer and scale-up of new processes from Chemical Development into Manufacturing.

• Scale-up of existing processes in Manufacturing.

• Responsible for writing and/or reviewing new process documentation (master batch records or data capture forms) and automated equipment methods.

• Responsible for revising and/or reviewing existing batch documentation and automated equipment methods for process improvements.

• Generate and/or review change control records (CC), risk assessments (RA), corrective and preventive actions (CAPA), and effectiveness verification records (EV) to maintain compliance with Current Good Manufacturing Practices (cGMP).

• Assist manufacturing with real-time problem solving and troubleshooting for processes and/or process equipment.

• Attend and participate in project team meetings to develop and execute project plans. Interface with Chemical Development and Manufacturing to ensure small-scale development activities will scale to manufacturing equipment and systems.

• Responsible for the review and approval of technical transfer documents from Chemical Development to ensure compatibility with process equipment.

• Coordinate the revision of standard operating procedures (SOP) as required to support new process implementation and/or scale-up.

• Responsible for the generation and/or review of batch summaries for all batches produced in the manufacturing facilities.

• Responsible for communicating future development requirements or opportunities to the project team.

• Actively lead or participate in the investigation of major process deviations including providing technical assistance to Quality Assurance (QA) on the final product impact assessment and identification of root cause as necessary.

• Bachelor's degree in chemistry, biology, engineering or related life science field; or an equivalent combination of education and related experience.

• 2+ years relevant experience required.

• Technical writing experience required.

• Prior experience with large-scale pharmaceutical or biopharmaceutical manufacturing unit operations preferred.

• Prior experience in a GMP manufacturing facility preferred.

• Experience coordinating and participating in interdepartmental project teams preferred.

• Knowledge of or experience with regulatory agencies and associated audits preferred.