Manager, Process Engineering

Simtra BioPharma Solutions - Bloomington, IN

Hiring: Manager, Process Engineering Company: Simtra BioPharma Solutions Location: Bloomington, IN Job Posted Time: 2026-09-11 13:51:40 Employment Type: Contract Target Skills & Keywords : Microsoft Excel About the job Experience: •10 years of experience in aseptic manufacturing •5 years supervisory experience •Minimum 10 years of experience in aseptic manufacturing •Minimum 5 years supervisory experience Required Skills: •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. Assist 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. •Utilize Lean principles to manage the successful completion of departmental tasks within the boundaries of quality, time, safety and budget. •Lead and oversee 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. Qualifications: •Bachelors degree in Engineering discipline required •Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.) •Must be able to gown qualify for Grade A/B are •Must be able to lift up to 50lbs. •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. •In return, you’ll be eligible for [1] Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!