Biopharmaceutical Process Equipment Lead
About the Role
This role will lead an area responsible for designing, specifying, installing, and starting up new and renovated biopharmaceutical process equipment.
Key Responsibilities
* Lead the Engineering team with clear expectations and set an example
* Provide supervision, coaching, and mentoring to direct reports and other Engineering staff
* Ensure team compliance with all departmental policies and procedures
* Design and specify cGMP process equipment, piping, and controls
* Manage projects related to process equipment and manufacturing
* SUPPORT REGULATORY COMPLIANCE EFFORTS THROUGH AUDIT PARTICIPATION AND QUALITY SYSTEMS DEVELOPMENT
* Evaluate, approve, prepare, and execute modification/change control documentation
* Participate in investigational, continuous improvement, and other improvement-related committees
* Provide headcount forecasts for future growth of the department to senior management
* Maintain the company's reputation by ensuring compliance with local, state, and federal regulations
Requirements
* Extensive experience leading engineering projects within the biopharmaceutical or other GMP-regulated industries
* Proven record of successfully delivering capital projects using project management best practices
* Highly skilled in people leadership, with experience in building and developing high-performance teams
* Excellent communication, negotiation, and stakeholder management skills
* Able to think strategically and execute tactically in a fast-paced environment
Education and Experience
Bachelor\'s degree in Chemical or Biochemical Engineering or higher required. 10 years of direct experience in biopharmaceutical equipment, process, or facilities engineering or equivalent combination of education and experience.