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 role is suited to someone with experience in pharmaceuticals or biologics, GMP manufacturing, or another highly regulated industry. The Manufacturing Specialist sets up and safely operates production equipment, works hands-on in manufacturing, and contributes to continuous process improvement. The specialist takes ownership of the quality and quantity of product produced, troubleshoots equipment, and uses mechanical aptitude and problem-solving skills to support production. The position also calls for mentoring and leadership to motivate manufacturing personnel, keep production activities on schedule, and encourage solution-focused thinking. This role is designed for the weekend day shift: Friday through Sunday, 12-hour shifts from 6:00 a.m. to 6:00 p.m., totaling 36 hours per week. Additional hours may be required to support operational needs. Unless otherwise specified, positions are based at INCOG BioPharma's Fishers, Indiana offices. The campus is smoke-free. Applicants must be authorized to work full-time in the United States; the company does not sponsor work authorization or visas for this role.
Requirements
- High school diploma.
- Three years of GMP pharmaceutical experience with installation, operation, cleaning, and maintenance of pharmaceutical filling equipment.
- Working knowledge of MS Office, MS Word, MS Excel, and Windows or equivalent.
- Authorization to work in the United States on a full-time basis; work authorization or visa sponsorship is not provided.
Nice To Haves
- Bachelor of Science in biological sciences or biotechnology, with one year of GMP pharmaceutical experience involving 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 concepts such as 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
