Manager, Process Engineering
Simtra BioPharma Solutions · Bloomington, IN · Yesterday
On-siteEngineeringFull-time
Responsibilities
- Provides guidance, support, direction and leadership through positive interactions with all personnel during daily operations (24/7).
- Interviews, hires, coaches, and develops staff.
- Conducts annual performance reviews for all direct reports.
- Aids in setting performance objectives and development plans.
- Manages a team of engineering professionals to support aseptic processing, filling and packaging equipment processes.
- Oversee departmental capital equipment budgets, Value Improvement Projects, and equipment/process optimization.
- Ensures department compliance for master change control management and validation protocols.
- Utilizes Lean principles to manage the successful completion of departmental tasks within the boundaries of quality, time, safety and budget.
- Responsible for overall management of project timelines associated with generating equipment design specifications, procurement, design of experiments, factory acceptance testing, installation, coordination of validation activities, standard operating procedure (SOP) generation, and transfer to functional area for in-service status.
- Provides guidance on design and technical direction to engineering staff.
- Provides review and approval of Engineering Work Orders, Master Change Controls, Exception Reports, Technical Summaries, Validation protocols, expense approvals and CAPA's.
Requirements
- Bachelor’s degree in Engineering discipline required.
- Advanced degree preferred.
- Minimum 10 years of experience in aseptic manufacturing.
- Minimum 5 years supervisory experience.
- Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.).
Physical / Safety Requirements
- Must be able to gown qualify for Grade A/B.
- Must be able to lift up to 50 lbs.
- Duties may require overtime work, including nights and weekends.
- Use of hands and fingers to manipulate office equipment is required.
- Position requires sitting or standing for long hours.