CAPA Process Engineer

An internationally renowned pharmaceutical organisation is seeking to hire a CAPA Pricess Engineer for their office in the US. This historic company, which has been established for well over a century, prides itself on its work across multiple therapy areas, including cardiovascular, neurology, and immunology. This is an exciting opportunity to work with one of the most prestigious pharmaceutical establishments in the world.

Job Responsibilities:

• Execute corrective actions/preventive actions (CAPA).
• Change control projects for aseptic improvement projects resulting from regulatory inspections and internal aseptic assessments/audits.

Skills and Requirements:

• Sound technical knowledge.
• Experience with pharmaceutical aseptic and sterile manufacturing process development, process improvement, current regulations, and regulatory inspections trends.
• Working knowledge of Trackwise/change control systems.
• Qualified candidate must have ability to own and manage complex change controls and CAPAs resulting from regulatory inspections and internal audits.
• Working knowledge of the following pharmaceutical systems is preferred:
  • Bosch TL-style filling machines for liquid and lyophilized vials
  • Bausch & Stroebel cartridge filling machines
  • IMA vial filling machines (CIP/SIP and single use fluid pathways)
  • Steam sterilization autoclaves
  • Sterilisation validation
  • Aseptic process simulation (media fills)
  • Environmental monitoring in aseptic/sterile manufacturing
  • Process FMEA/risk assessments

• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at +44 207 440 0679 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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