Night Shift GMP Manufacturing Specialist (Fill/Finish)

INCOG BioPharma Services; Fishers (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

INCOG BioPharma is seeking a highly motivated Manufacturing Specialist with SME capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. This 3rd shift role (Sun-Thu, 11:00 PM–7:30 AM) is a key technical position within INCOG BioPharma Operations, requiring experience in GMP manufacturing or related regulated environments.

You will follow procedures, operate sterile filling equipment, document batch records, support validations, and train others in

Qualifications

• High School diploma and 3 years of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical filling equipment.
• Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required.
• BS in biological sciences/biotechnology and 1 year of GMP pharmaceutical experience with the installation, operation, cleaning, and maintenance of pharmaceutical GMP equipment.
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing (fill and finish) general Good Manufacturing Practices (cGMP).
• Excellent communication skills.
• 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.

Responsibilities

• Follow production and manufacturing procedures.
• 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.

Skills

MS Office

MS Word

MS Excel

Windows

Communication skills

GMP knowledge

Education

BS in biological sciences/biotechnology

Tools

ERP systems

Inventory management systems

Job description

INCOG BioPharma is seeking a highly motivated Manufacturing Specialist with SME capabilities in sterile pharmaceutical manufacturing process controls and industrial automation. This 3rd shift role (Sun-Thu, 11:00 PM–7:30 AM) is a key technical position within INCOG BioPharma Operations, requiring experience in GMP manufacturing or related regulated environments.

You will follow procedures, operate sterile filling equipment, document batch records, support validations, and train others in