Filling Equipment Specialist, Weekend Day Shift
About The Position
INCOG BioPharma is seeking a Filling Equipment Specialist with subject matter expertise in sterile pharmaceutical manufacturing process controls and industrial automation. This hands-on technical role within BioPharma Operations is responsible for setting up and safely operating production equipment, supporting quality and production output, and contributing to continuous improvement. The specialist provides technical support to process engineering and operations, including troubleshooting, repairs, and preventative maintenance of equipment and processes. The role also involves mentoring manufacturing personnel and adapting to changing manufacturing needs. The position works in Grade C, Grade D, and controlled non-classified cleanrooms, and performs aseptic manipulations within Grade A isolators. It is based at INCOG BioPharma's Fishers, Indiana offices unless otherwise specified. The scheduled weekend day shift runs Friday through Sunday, 6:00 a.m. to 6:00 p.m., for 36 hours per week. Additional hours may be required to support operational needs.
Requirements
- High school diploma.
- Seven years of GMP pharmaceutical experience with installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.
- Working knowledge of MS Office, MS Word, MS Excel, and Windows or equivalent.
- Strong mechanical aptitude and troubleshooting skills with manufacturing equipment.
- Ability to adapt to changing manufacturing needs and provide equipment and process troubleshooting, repair, and preventative maintenance support.
- Ability to work the weekend day shift, with additional hours as needed.
Nice To Haves
- Bachelor of Science in biological sciences or biotechnology and one year of GMP pharmaceutical experience with installation, operation, cleaning, and maintenance of 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.
- Experience in pharmaceuticals, biologics, GMP manufacturing, or other highly regulated industries.
- Mentoring and leadership skills to motivate manufacturing personnel, drive timely production activities, and encourage problem-solving.
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.
- 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 issues arising in day-to-day operations and provide timely responses and solutions.
- Serve as the subject matter expert for filling equipment and supporting systems.
- Participate in or support process FMEAs to understand process and product risks before process validation.
- Provide technical support for manufacturing activities.
- Apply Good Engineering Practices to support site engineering and operational excellence.
- 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
Senior
Education Level
High school or GED
