3rd Shift Aseptic GMP Fill/Finish Specialist & Team Lead

INCOG BioPharma Services; Fishers (IN); On-site; USD 60,000 - 90,000; Full time

Job summary

INCOG BioPharma Services is seeking a Manufacturing Specialist to join our Operations team in Fishers, IN. This hands-on role focuses on GMP manufacturing for pharmaceutical or biologics products, with ownership of production quality and yield.

The ideal candidate has strong mechanical aptitude, troubleshooting skills, and proven ability to mentor and lead manufacturing staff. This is a 3rd shift position (Sun-Thu, 11:00 PM–7:30 AM) with emphasis on batch start-ups, data documentation, and

Qualifications

• High School diploma and 3 years of GMP pharmaceutical experience with the operation, cleaning, and maintenance of pharmaceutical GMP equipment.
• Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required.
• Must have previous experience with pharmaceutical aseptic processing (fill and finish) cGMP.

Responsibilities

• Follow production and manufacturing procedures.
• Perform duties in Grade C, 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 execution of production cycles
• 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.
• Resolve issues that arise in day to day running of operation and providing timely responses and solutions.
• SME for filling equipment and supporting systems.
• Participate and/or support process FMEAs to understand process and product risks as a pre-requisite for process validation.
• Provide technical support to manufacturing activities.
• Apply Good Engineering Practices (GEP) to drive site engineering and operational excellence.
• Work flexible hours to ensure production facility coverage.

Job description

INCOG BioPharma Services is seeking a Manufacturing Specialist to join our Operations team in Fishers, IN. This hands-on role focuses on GMP manufacturing for pharmaceutical or biologics products, with ownership of production quality and yield.

The ideal candidate has strong mechanical aptitude, troubleshooting skills, and proven ability to mentor and lead manufacturing staff. This is a 3rd shift position (Sun-Thu, 11:00 PM–7:30 AM) with emphasis on batch start-ups, data documentation, and