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Process Engineer, Finishing Specialist

1 month ago

Kinston, North Carolina, United States West Pharmaceutical Services Full time
Job Summary:

The HVP Process Engineer will organize, coordinate, create and perform modifications, validations, and enhancements of processes, procedures, equipment and tooling to new and existing products and processes related to B2 Coating, Pharma Washing, Envision Processing and Sterilization.


Key Responsibilities:

  • Support the implementation, development, transfer and improvements of processes and products within the facility related to pharma wash, sterilization and clean room production.
  • Initiate, support and execute HVP processing related CAPAs, Quality Initiatives or Complaints.
  • Ensure compliance to cGMP's, Validation Master Plans, FDA and other regulatory agency initiatives.
  • Plan, guide, coordinate or perform modifications, improvements or new initiatives for new or existing products or processes within pharma wash, sterilization and clean room technologies.
  • Support and recommend new and experimental product development activities related to pharma washing, sterilization and clean room processing.
  • Ensure Engineering records and documentations related to equipment, products, and product development are accurately recorded per Validation Master plans and are properly maintained.
  • Review/Revise procedures to ensure they reflect the most current and effective means of describing processes.
  • Support and Champion West Values to ensure the success of the Kinston site and West as a Global Market Force.
  • Safeguard confidential information.
  • Maintain and promote effective team member relations, ensuring that we have team member agreement of new layouts or procedures.
  • Conforms with and abides by all regulations, policies, work procedures, instructions and safety policies.

Requirements:

  • Bachelor's degree in Engineering or equivalent experience with science discipline.
  • Excellent written and verbal skills.
  • Excellent interpersonal skills; good team player and individual contributor.

Preferred Knowledge, Skills and Abilities:

  • Sterilization and Pharma Wash experience.
  • Working knowledge of cGMP for Aseptic/Clean Room manufacturing.
  • Working knowledge of Validation life cycle and processes for regulated industries.
  • Ability to author/execute validation protocols, SOP's/SOI's.
  • Working knowledge of Minitab or SPC software for tracking and trending KPI's/performance.

Travel Requirements:

  • Travel up to 10%.

Physical & Mental Requirements:

  • Office and manufacturing environment.
  • Ability to lift files, open filing cabinets and bend or stand as necessary.
  • Must follow and comply with Plant's Dress and Hygiene Code (SOI)
  • Regularly uses hands and fingers to operate objects, tools or controls. Frequently required to stand, talk and hear for long periods of time.