Manufacturing Operator

About the role

The Manufacturing Operator will perform duties assigned in production areas for the manufacture and packaging of finished drug products. This role will maintain the clean rooms, packaging room and equipment used in the manufacturing of drug products. Incumbent will be working in class 10,000 production rooms in a cGMP manufacturing area. This role will be required to produce and manufacture drug products according to specifications and batch record requirements by using appropriate machinery, equipment and materials. Perform environmental monitoring in clean rooms.

Responsibilities

• Performs all tasks related to the manufacture and packaging of finished drug products independently.
• Executes and documents master batch formulas and logbooks at the highest level of cGMP compliance independently.
• Successfully performs the master formulas independently to complete the training process.
• Participates in investigations and root cause analysis as needed.
• Performs monomer/cartridge production, blending/pellet production and implant production.
• Sterilizes primary packaged drug products in steam autoclave.
• Packs bulk drug products into appropriate primary container closure system.
• Packs drug products into appropriate secondary packaging container/shippers.
• Participates in clean room and equipment maintenance.
• Performs environmental monitoring in clean rooms.
• Participates in process and cleaning validation activities as required.

Qualifications

• High School Diploma or equivalent is required.
• Minimum 2-4 years’ experience working in a cGMP manufacturing facility, preferably in a clean room environment.
• Minimum 2-4 years’ experience operating pharmaceutical manufacturing, packaging or labeling equipment.
• Knowledge of cGMP regulations.
• Must be able to read / write, follow written / oral instructions and read / understand Master Formulas, work instructions, and SOP’s.
• Knowledge of workplace health and safety requirements for applicable hazardous substances.

Skills & Abilities

• Ability to work in a team environment.
• Ability to follow instructions.
• Good communication skills.
• Ability to perform machine set-up, adjustments and operations.
• Possess general computer skills.
• Ability to interact with other departments.

Physical Requirements

• Ability to work overtime when required.
• Ability to wear respirators and other protective equipment.
• Ability to wear cleanroom garments and work in a class 10,000 production rooms.
• This position requires working with or around hazardous substances, and is subject to work restrictions and precautions as set forth in the Safety Data Sheet, provided to all affected employees.
• Keenova offers employees a Total Rewards package which includes competitive pay and benefits.