Process Engineering Manager

Primary Function

The person in this position is responsible for providing leadership to the Process Engineering team and process engineering projects to support operations and product quality. This position is responsible for coordinating resources necessary to drive completion of work.

Personnel

• Provide direction to team members about daily tasks and long-term goals related to company strategy and project completion.
• Support process engineering efforts, as resourced by Process Engineering. Such support will include hiring, training, motivating, evaluating, and scheduling.
• Collaborate to set process engineering priorities based on company needs.
• Provide personnel support for the following activities: CIE projects, process risk analysis, NCMR response, deviation response, NC investigations, ETI event response, completion of ECPs, and regulatory support.
• Conduct performance appraisals and wage reviews for direct reports.

Processes

• Manage the process of completing process engineering projects.
• Establish metrics to measure performance and output of process engineering work.
• Provide input on and help drive continuous improvement of key process engineering responsibilities including project management, risk analysis, process validation, and process development.
• Review and pre-approve change requests.
• Participate in change control committee (CCC) meetings.
• Participate in process risk analysis meetings (RCG and RCCC).
• Maintain the master validation plan (MVP) and master PFMECA index (MPI) and ensure completion of required periodic updates.
• Ensure timely completion of process validation review reports.

Communication

• Ensure direct reports are well-informed about company information, events, processes, and priorities.
• Work with other CBI leaders to ensure proper communication channels exist between process engineering and other areas.
• Understand available data related to CBI manufacturing and use the information to drive conversations about project priorities

Other

• Remain current and apply the understanding of FDA-ISO 13485 and Quality System Requirements in carrying out duties.
• Administer and ensure compliance to the Cook Biotech and OSHA/IOSHA requirements for Hazard Communication
• Conduct other corporate duties when required.

Minimum Work Experience/Educational Requirements

• Excellent written and verbal communication skills
• Proven ability to lead and manage projects
• Proven ability to communicate and work constructively with colleagues to establish and achieve mutual goals
• Sufficient background to generally understand process validation processes
• Bachelor's degree in engineering with extensive work experience in process validation
• At least four years industry experience in medical device manufacturing and process validation
• At least four years of previous management experience.
• Willing to work with material derived from animal tissues

Physical Requirements/Work Environment

• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Limited exposure to hazardous chemicals used in the manufacture of the product.
• Physical demands are typical of an office and classroom environment.