The 2nd Shift Manufacturing Specialist on the Filling Line's primary responsibility is to efficiently and safely setup and operate various pieces of production equipment within the facility. They will be expected to work hands-on, be actively involved in continuous process improvements while taking ownership of the quality and quantity of product produced. The ideal candidate should possess a strong mechanical aptitude with strong trouble shooting skills on manufacturing equipment. They should demonstrate mentor and leadership skills to motivate manufacturing personnel, drive timely production activities and inspire problem solving & solution driven thinking.
Key responsibilities: Perform duties in Grade C, 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/engineering protocols as needed.Train others in various manufacturing tasks including, but not limited to fill/finish, sanitization, component and equipment preparation.Maintain production equipment and troubleshoot issues.Support equipment optimization efforts and continuous improvement efforts.Collaborate and communicate with cross functional teams.Work flexible hours to ensure production facility coverage. Minimum Requirements: 3 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, Windows or equivalent is requiredHigh School diploma, with preferred BS in Biological Sciences Additional Preferences: Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish) general Good Manufacturing Practices (cGMP)Excellent communication skillsAbility to apply concepts such as fractions, percentages, ratios and proportions to practical situationsAbility to learn and operate a range of industry systems including and not limited to ERP and inventory management systems Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. ?All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.