Within this role, you will lead an area responsible for designing, specifying, installing, and starting up new and renovated biopharmaceutical process equipment. You will provide engineering support and problem-solving for existing equipment and manufacturing processes.
A typical day might include, but is not limited to, the following:
1. Leading the Engineering team with clear expectations and by setting an example
2. Providing supervision, coaching, and mentoring to direct reports and other Engineering staff
3. Ensuring team compliance with all departmental policies and procedures
4. Designing and specifying cGMP process equipment, piping, and controls
5. Managing projects related to process equipment and manufacturing
6. Supporting regulatory compliance efforts through audit participation and quality systems development
7. Ensuring accurate completion of all departmental projects and work, including work orders and process items
8. Supporting manufacturing and maintenance activities as a technical advisor
9. Recommending appropriate corrective/preventive actions for existing processes
10. Evaluating, approving, preparing, and executing modification/change control documentation
11. Participating in investigational, continuous improvement, and other improvement-related committees
12. Providing headcount forecasts for future growth of the department to senior management
13. Maintaining the company's reputation by ensuring compliance with local, state, and federal regulations
This role may be for you if:
1. You have extensive experience leading engineering projects within the biopharmaceutical or other GMP-regulated industries
2. You have a proven record of successfully delivering capital projects using project management best practices
3. You are highly skilled in people leadership, with experience in building and developing high-performance teams
4. You possess excellent communication, negotiation, and stakeholder management skills
5. You have the ability to think strategically and execute tactically in a fast-paced environment
To be considered for this opportunity you should have a BS/BA or higher in chemical or biochemical engineering with 10 years of direct experience in biopharmaceutical equipment, process, or facilities engineering or equivalent combination of education and experience.
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