Manufacturing Specialist - Filling, 2nd shift
$73,216,000–$84,656,000 year
On-siteFishers, Indiana, United States
Job Summary
Operate production equipment including setup and changeovers, lead batch start up activities, and execute production cycles within Grade A isolators and controlled cleanrooms. Troubleshoot issues on filling manufacturing equipment, maintain systems, and support continuous improvement efforts. Accurately document data, complete batch records, and execute validation/engineering protocols. Train personnel in manufacturing tasks and provide technical support to drive operational excellence. Resolve day-to-day operational issues with timely responses and solutions. This 2nd shift role (3:00 PM–11:30 PM, Mon–Fri) requires 7 years of GMP pharmaceutical experience with aseptic processing expertise. INCOG BioPharma is building a world-class CDMO for parenteral injectable drugs focused on technical excellence and customer value.
Required Qualifications
- experience in pharmaceuticals and/or biologics
- GMP manufacturing
- strong mechanical aptitude
- trouble shooting skills on filling manufacturing equipment
- mentor and leadership skills
- High School diploma
- 7 years of GMP pharmaceutical experience
- experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment
- Working knowledge of MS Office
- Working knowledge of MS Word
- Working knowledge of MS Excel
- Working knowledge of Windows
- previous experience with pharmaceutical aseptic processing (fill and finish) cGMP
- Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations
- Ability to learn and operate a range of industry systems including and not limited to ERP and inventory management systems
- Must be able to work flexible hours to ensure production facility coverage
- Must be able to work 2nd shift
- Must be able to work Monday-Friday from 3:00PM-11:30PM
- Must be able to work in a smoke-free campus environment
Desired Qualifications
- BS in biological sciences/biotechnology
- 1 year of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment
- Excellent communication skills
- Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations
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