Clinical Manufacturing Operator

Clinical Manufacturing Operator

Requirements

• Understand and follow current Good Manufacturing Practices
• Perform routine operations utilizing formulation and filling equipment in Grade C/D areas and Grade A filling isolator
• Utilize computer software and HMI (Human Machine Interface) to control automated equipment
• Troubleshoot process problems and respond to process alarms
• Complete calculations to determine the amount of material to add based on final weight and sometimes potency
• Retrieve and test in-process samples
• Perform routine cleanup and sanitizations assigned by area supervision to maintain cGMP compliance within the Grade A/B/C/D work areas
• Always maintain organization within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches
• Perform environmental monitoring; including fingertip, contact, and fallout plates as required
• Assist in the training and development of other team members on processes in which they are qualified

Responsibilities

No responsibilities provided.

Preferred Qualifications

• High school diploma or GED required
• 2 years of experience operating and troubleshooting complex production equipment preferred
• 1 year pharmaceutical manufacturing related experience preferred
• Knowledge of cGMP manufacturing preferred
• Knowledge of basic laboratory and pharmaceutical production equipment including, but not limited to: filling machines, autoclaves, weight scales, pallet wrappers, etc. preferred
• Prior work in clean room environments (ISO 5/7/8, Grade A/B/C/D) preferred
• Knowledge, assembly, and operation of filling machines and filtration systems preferred
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software preferred (examples include: JDE, BPLM, MAXIMO, Trackwise, etc.)