Manufacturing Specialist - Filling, Weekend Day Shift
About The Position
INCOG BioPharma is seeking a Manufacturing Specialist with subject matter expertise in sterile pharmaceutical manufacturing process controls and industrial automation. This is a key technical role within INCOG BioPharma Operations. The specialist sets up and operates production equipment safely and efficiently, works hands-on to improve processes, and takes ownership of product quality and output. The role also involves troubleshooting manufacturing equipment, mentoring and supporting manufacturing personnel, and helping drive timely production and solution-oriented problem solving. The position works in Grade C, Grade D, and controlled non-classified cleanrooms, as well as performing aseptic manipulations within Grade A isolators. Duties include cleaning and sanitization, equipment preparation, aseptic filling, production equipment setup and changeovers, batch-record documentation, validation and engineering protocols, training, equipment maintenance and troubleshooting, optimization, and collaboration with cross-functional teams. The role is designed for weekend day shift: Friday through Sunday, 12-hour shifts from 6:00 a.m. to 6:00 p.m. (36 hours per week). Additional hours may be required to support operational needs. Unless otherwise specified, INCOG BioPharma positions are based at its Fishers, Indiana offices. The campus is smoke-free.
Requirements
- High school diploma.
- Three years of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical filling equipment.
- Working knowledge of MS Office, MS Word, MS Excel, and Windows or equivalent.
- Strong mechanical aptitude and troubleshooting skills on manufacturing equipment.
- Ability to work hands-on and take ownership of product quality and quantity.
- Mentor and leadership skills to motivate manufacturing personnel, drive timely production activities, and encourage problem solving and solution-driven thinking.
Nice To Haves
- Bachelor of Science in biological sciences or biotechnology, with one year of GMP pharmaceutical experience installing, operating, cleaning, and maintaining pharmaceutical GMP equipment.
- Demonstrated knowledge of biotechnology product manufacturing, aseptic processing (fill and finish), and general cGMP.
- 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.
Responsibilities
- Follow production and manufacturing procedures.
- Perform duties in Grade C, Grade D, and controlled non-classified cleanrooms.
- Perform aseptic manipulations within Grade A isolators.
- Perform cleaning and sanitization, equipment preparation, and aseptic filling duties as needed.
- Safely operate production equipment, including setup and changeovers.
- 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.
- Collaborate and communicate with cross-functional teams.
- Work flexible hours to ensure production facility coverage.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
