Biomanufacturing Technician, Central Services

Position Summary

This is an entry level position in the Manufacturing team and is the starting point to acquiring skills and training required for a cGMP biomanufacturing environment. The Technician is responsible for the manufacture of biopharmaceutical products within a clean room environment. The position is expected to follow detailed instructions and established procedures with frequent supervision.

The Role

• Perform basic buffer preparation activities, including weighing raw materials for production
• Accurately follows manufacturing Batch Production Records (BPRs) and Standard Operating Procedures (SOPs) in accordance with current Good Manufacturing Practices (cGMPs) and with a focus on right first time execution
• Documents all activities in accordance with Good Documentation Practices (GDPs) in BPRs, Forms, and other quality documentation
• Recognizes deviations from the intended procedure and raises awareness through the Rapid Response process
• Proactively identifies safety, quality, and efficiency improvements; Actively participates in the Catalent Way (Continuous Improvement Culture)
• May lead Just Do It (JDI) Continuous Improvement (CI) activities and engage in implementation of CI projects
• May coach more junior team members on basic execution activities and act as an onboarding buddy to facilitate bringing new team members quickly up to speed on culture and basic workplace expectations
• Performs general cleanroom housekeeping, including room and equipment cleaning, disposal of waste, and maintenance of 5S standards
• Other duties as assigned

The Candidate

• Must have High School Diploma or equivalent. No additional experience required
• GMP manufacturing experience preferred
• Ability to use Microsoft Word and Excel, and other Office systems
• Preferred experience with TrackWise, ComplianceWire, JD Edwards, DeltaV, Chromatography software
• Physical requirements: This position requires frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening. Occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. Must comply with EHS responsibilities for the position. Working conditions will be Heating Ventilation and Air Conditioned controlled. Ability to operate within a clean room environment as needed.