Manager, Process Engineering

Manager, Process Engineering

The Manager, Process Engineering is responsible for ensuring that the equipment, utilities, and facility is designed, installed, start-up, commissioned and operates as per specifications in addition to provide engineering support during validation. Incumbent will coordinate with the Facilities, Engineering, Validation, Operations and Quality Control and Quality Assurance Teams to ensure maximum uptime and efficiency of all systems and equipment.

Specific Responsibilities:

• Manage the Process Engineering team for a cell therapy manufacturing facility.
• Develop the scope of proposed future equipment projects for cost and schedule.
• Implement process improvements including the selection and modification of new equipment and facilities.
• Author, review, and edit technical documents, including drafting and approval of Equipment Specification, Test Protocols, SOPs, CAPAs, Change Controls, etc. Perform basic revisions as needed to accurately reflect current procedures. Review and edit documents created by other team members for accuracy, clarity, and consistency.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP). Completes recording of data to comply with regulatory requirements.
• Ensure that all documentation is compliant with internal requirements, regulatory requirements, including FDA, EMA, and ISO standards.
• Attends regular management meeting to discuss timelines and priorities.
• Manage multiple projects to ensure timely initiation and completion of work.
• Maintain effective communication with project team members, contractors, and vendors.
• Liaison with the equipment and engineering vendors to support manufacturing and quality control.
• Create user requirements specifications for new projects.
• Training maintenance and operative staff when appropriate.
• Maintain our Engineering documentation and drawings.
• Oversee contractors when troubleshooting and professional repairs are necessary.
• Scheduling and Coordinating work in tight deadlines.
• Present our programs to agency auditors as required.

Education and Qualifications:

• BS or MS in Engineering field is required, or equivalent experience.
• 8 years of related BioPharma/Life Sciences experience required. Prior experience in cell therapy manufacturing is highly desirable.
• Has comprehensive understanding of principles, theories, concepts, and industry practices and standards and their application.
• Extensive knowledge of small-scale cell culture processes and techniques is preferred.
• Experience interfacing with other design disciplines including automation, facility design and mechanical design groups is required.
• Experience interfacing with CQV and operations teams is required.
• Experience in scheduling and budgeting Facilities & Process Engineering efforts is highly desirable.
• Demonstrable experience on cGMP capital, continuous improvement and operating projects.
• Excellent oral and written communication skills required.
• Exceptional attention to detail and follow-through.
• Excellent verbal and written skills in communicating regulatory and technical information.

Physical Requirements:

• Stand for long periods of time (2-4 hours).
• Lift up to 15 lbs.
• Sit for extended period of time in front of computer (2-4 hour).