Operator I, Manufacturing (12hr nights)

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 the manufacturing equipment for filling 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.

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.

• Ensures pharmaceutical products are manufactured in accordance with area SOPs and current cGMP.
• Verify and document production activities in batch records, logbooks, and controlled forms.
• Operate vial tray loaders.
• Filter integrity testing.
• Clean pre and post use change parts and prep for sterilization.
• Maintain/clean classified and non-classified areas. This includes but is not limited to the aseptic core.
• Record and complete accurate documentation according to GMP requirements.
• Drive a culture of safety and quality in all activities.
• Perform visual inspections on in-process and finished products and call out inconsistencies when appropriate.
• Work with a team in a fast-paced environment assembling product.