HVP Operator (Kinston, North Carolina, US) bei West Pharmaceutical Services, Inc.

Job Summary

To work as a team member to process High Value Products (HVP) through the HVP process with minimal assistance from management or engineering. Team members must have the ability to work with other team members in a cell concept rotating through multiple job functions throughout the day following a playbook for optimal performance. Team members must be able to perform job functions with a full gown/goggles in which no skin is visible within the area for multiple hours at a time.  Ideal candidates are quick thinking and confident to ensure consistent processing and foresight to know the next task required.  It is the responsibility of this individual to ensure that product/customer specifications are followed always.  Ideal candidates have previous cGMP experience and have the knowledge of how to operate within a classified clean room.

Essential Duties and Responsibilities

• Strictly adhere to all requirements pertaining to gowning for entry into classified clean room areas.
• Candidates must be able to pass gowning qualifications to enter classified clean rooms.
• Accurately maintain all required documentation and paperwork to ensure lot traceability.
• Operate pharma wash equipment and oversee processes within classified clean rooms such as pre-staging, staging, loading, unloading and final packaging, per cGMP standards.
• Strict adherence to product/customer specifications.
• Ensure that weigh/count equipment is set up accurately and within calibration.
• Correctly sample product for QA inspections and pre-delivery samples in cGMP manner.
• Keep equipment and work area in clean and orderly condition.
• Operate Envision system correctly according to all applicable procedures.
• Operate steam sterilization process including but not limited to start functions such as loading, unloading and packaging.
• Input and log data correctly for the Autoclave process when needed.
• Perform all positive pressure and cleaning requirements for all classified cleanrooms associated with the HVP Processing department.
• Alert the Area Manager to conditions that may prevent meeting production and quality expectations.
• Operate PC, printers and scanners as required.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules. 

Education

• High School Diploma or GED Required. 

Work Experience

• Experience: 2+ years of cGMP manufacturing experience.
• Must possess an acute attention to detail and be willing and able to work in a team environment.
• Make good decisions within authorized job responsibilities.

Preferred Knowledge, Skills and Abilities

• <10% as needed.
• Must have corrected or uncorrected vision of 20/30 or better.
• Must pass color vision test.
• Must be able to gown into required clothing for a controlled clean room.
• Frequent standing, walking, twisting, bending, reaching, pushing, pulling.
• Must be able to frequently change tasks/operations following a playbook for relief of team.
• Must be able to work/lift items weighing up to 50 lbs.
• Must also be able to tolerate industrial odors and smells on a frequent basis. 

Travel Requirements

Physical Requirements