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West Pharma HVP Operator United States, North Carolina 597436804
17.04.2025
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 .
Additional Responsibilities
Education
- High School Diploma or GED preferred.
- Must pass pre-employment testing.
Work Experience
- Experience: 2-4 years of cGMP manufacturing experience.
Preferred Knowledge, Skills and Abilities
- Must possess an acute attention to detail.
- Basic computer skills, i.e. use a mouse/keyboard.
- Ability to apply Good Manufacturing Practices (GMP)
- General use of computer work station and ability to use SAP commands is preferred.
- Must be willing and able to work as a team member and make general decisions within authorized job responsibilities.
- Must be able to train and guide others as required.
- Must be able to read and write in English
- Preferred candidate will have experience working in or processing in a controlled clean room and have knowledge of cGMP requirements for controlled environments.
License and Certifications
Physical Requirements
Medium-Exerting up to 50lb/22kg of force occasionally and/or up to 20lbs/9kg of force frequently, and/or up to 10lbs/4kgs of force constantly to move objects.
Additional Requirements
- Must have corrected or uncorrected vision of 20/30 or better.
- Must pass color vision test.
- Must be able to tolerate industrial odors and smells on a frequent basis.
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