Operator I, Manufacturing - 3rd Shift

at  Thermo Fisher Scientific

GROUP/DIVISION SUMMARY

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

POSITION SUMMARY

The Manufacturing Operator will be responsible for visually inspect and package pharmaceutical products in a clean room environment. They will carry out the production process by closely following the Standard Operating Procedures (SOP) and Work Instruction Documents as they relate to assembly, materials handling, equipment operation, and finished products. Typical hours are Sunday – Thursday 8PM – 6AM, sometimes Friday 8PM – 2AM.

QUALIFICATIONS:

• High school diploma or equivalent required
• Excels in a team environment.
• Basic math skills.
• Good verbal/written communication.
• Attention to detail while maintaining a quality product.
• Ability to perform repetitive work duties.
• Ability to follow SOPs.

PHYSICAL REQUIREMENTS:

• Work in a clean-room which is a controlled environment for temperature and humidity having low ambient noise.
• Wear gowning which includes: gloves, hair & beard net and face cover, safety glasses with no makeup / jewelry, and the like.
• Use Personal Protective Equipment (PPE) and understand chemical hygiene.
• Infrequently lift and manipulate up to 25 pounds max unassisted.
• Stand and move about including reaching, bending, stooping, grasping.
• Use hand tools and equipment including forceful gripping, grasping, pushing and pulling.
• Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds.

• Apply packaging and/or inspection equipment to pack containers of products according to approved departmental Standard Operating Practices (SOPs), SOMs and PWOs and ensure all in-process and completed work is accurate. Ensure it is cleared for access to controlled substance.
• Purge lines of components before and after packaging operations begin. Supply and service line with packaging components specified on the packaging work order.
• Examine product visually for accurate physical quality (i.e., accurately filled, sealed, labelled, etc.) and report any irregularities observed during the packaging process to lead or supervision.
• Perform equipment cleaning.
• Make sure to safely operate mobile equipment, store and transport required materials to accurate areas for use.
• Check receipt of packaging components or delivery of finished stock for quality, quantity, and agreement with packaging work order.
• Complete all required documentation.
• Maintain proper personal hygiene as required by Current Good Manufacturing Practices (CGMPs).
• Demonstrate punctuality and sense of responsibility through adherence to attendance guidelines.
• Perform other duties as assigned.