Filling Equipment Specialist, Weekend Day Shift
About The Position
INCOG BioPharma is seeking a highly motivated Filling Equipment 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, takes ownership of product quality and quantity, and contributes hands-on to continuous process improvement. The role also provides technical support to process engineering and operations, including troubleshooting, repairs, and preventive maintenance of manufacturing equipment and processes. The successful candidate has strong mechanical aptitude and troubleshooting skills, can adapt to changing manufacturing needs, and demonstrates mentoring and leadership abilities to support production personnel, timely production activities, and solution-oriented problem solving. The position supports filling equipment and associated systems in a regulated pharmaceutical manufacturing environment. The role is based at INCOG BioPharma’s Fishers, Indiana offices unless otherwise specified. INCOG describes its culture as focused on customer service, technical excellence, collaboration, and a team-centered approach. The campus is smoke-free. Applicants must be authorized to work in the United States; the company will not sponsor work authorization or visas for this role.
Requirements
- High school diploma.
- Seven years of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.
- Working knowledge of MS Office, MS Word, MS Excel, and Windows or equivalent.
- Experience in pharmaceuticals and/or biologics, GMP manufacturing, or another highly regulated industry.
- Strong mechanical aptitude and troubleshooting skills with manufacturing equipment.
- Ability to adapt to changing manufacturing needs.
- Ability to demonstrate mentoring and leadership skills.
- Excellent communication skills are listed as an additional preference.
Nice To Haves
- Bachelor of Science in biological sciences or biotechnology, plus one year of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.
- Demonstrated knowledge of biotechnology product manufacturing, aseptic processing (fill and finish), and general cGMP.
- 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.
- Safely operate production equipment, including setup and changeovers.
- Lead batch startup 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 as a prerequisite for 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
