Manufacturing Specialist - Filling, 3rd shift
About The Position
The Manufacturing Specialist is a hands-on technical role within INCOG BioPharma Operations, focused on pharmaceutical and/or biologics GMP manufacturing. The role takes ownership of product quality and quantity, contributes to continuous process improvements, and provides technical support for filling operations. It requires mechanical aptitude and troubleshooting ability with filling manufacturing equipment, along with the ability to mentor and motivate manufacturing personnel, drive timely production activities, and encourage problem solving. The position supports production in Grade C, Grade D, and controlled non-classified cleanrooms, including aseptic manipulations within Grade A isolators. The specialist operates, sets up, and changes over production equipment; leads batch start-ups and production cycles; documents work and completes batch records; and helps maintain, troubleshoot, and optimize equipment and processes. The role also trains colleagues, supports validation and engineering protocols and process risk assessments, and applies Good Engineering Practices to promote operational excellence. This is a third-shift position with flexible hours needed to ensure production facility coverage. Unless otherwise specified, positions are based at INCOG BioPharma’s Fishers, Indiana offices; the campus is smoke-free.
Requirements
- High school diploma.
- At least 3 years of GMP pharmaceutical experience operating, cleaning, and maintaining pharmaceutical GMP equipment.
- Working knowledge of MS Office, MS Word, MS Excel, and Windows or equivalent.
- Previous experience with pharmaceutical aseptic processing (fill and finish) under cGMP.
- Mechanical aptitude and troubleshooting skills for filling manufacturing equipment.
Nice To Haves
- Bachelor of Science in biological sciences or biotechnology, with at least 1 year of GMP pharmaceutical experience installing, operating, cleaning, and maintaining pharmaceutical GMP equipment.
- Excellent communication skills.
- Ability to apply fractions, percentages, ratios, and proportions to practical situations.
- Ability to learn and operate industry systems, including ERP and inventory management systems.
- Mentoring and leadership skills to motivate manufacturing personnel and encourage problem solving.
Responsibilities
- Follow production and manufacturing procedures.
- Work in Grade C, Grade D, and controlled non-classified cleanrooms.
- Perform aseptic manipulations within Grade A isolators.
- Safely operate production equipment, including setup and changeovers.
- Lead batch start-up activities and execute production cycles.
- Accurately document data and complete batch records.
- Execute validation and engineering protocols as needed.
- Train others in manufacturing tasks, including fill/finish, sanitization, and component and equipment preparation.
- Maintain production equipment and troubleshoot issues.
- Support equipment optimization and continuous improvement efforts.
- Resolve day-to-day operational issues and provide timely responses and solutions.
- Serve as a subject matter expert for filling equipment and supporting systems.
- Participate in or support process FMEAs to understand process and product risks as a prerequisite for process validation.
- Provide technical support for manufacturing activities.
- Apply Good Engineering Practices (GEP) to support site engineering and operational excellence.
- Work flexible hours to ensure production facility coverage.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
