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Microbiology & Sterility Assurance Specialist

Microbiology & Sterility Assurance Specialist

Posted 25 May by PALL Corporation
Ended

Find what drives you on a team with a 70+ year history of being recognized for discovery, determination, and innovation. As a global leader in high-tech filtration, separation, and purification, Pall Corporation thrives on helping our customers protect people. Whether your interests lie in Life Sciences, Aerospace, Microelectronics or Food & Beverage, you’ll find a rewarding role here. Our career opportunities are as diverse as our products and they are all focused on creating better lives and a better planet. At Pall, we believe that innovation is our legacy, our privilege and our destiny. If that resonates with you, join us!

Pall is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

Looking to improve your career within this fast paced environment? This could be the ideal next opportunity for you with great opportunities and benefits!

Role Summary:
To provide microbiological and sterility assurance expertise and to support microbiological product testing, product sterilisation (initial validation and dose auditing). The position will also require the application & compliance to international clean room standards and supervising activities related to manufacturing, design, installation, in-process control and personnel.

Main Responsibilities:

  • Ensure compliant sterilisation validation, revalidation and dose audit activity for Gamma and Ethylene Oxide product sterilisation cycles at multiple sites.
  • Ensure clean room environmental monitoring activities are complaint and monitored to establish priorities for compliance/improvement.
  • Ensure required practices and standards in the cleanrooms, site microbiology and subcontract laboratories are compliant and supervised to establish priorities for compliance / improvement.
  • Ensure compliant product development/transfer activities for sterile products.
  • Ensure cleaning practices are validated, effective and up to date.
  • Audit sterilisation and external test laboratory sub-contractors.
  • Provide technical input to microbiology based product testing activities.
  • Stay ahead of development of standards and best practice to ensure techniques and practices are kept up to date; recommend internal QMS / procedure changes as the need arises.
  • Conduct manufacturing and quality system audits in accordance to ISO 13485 and relevant microbiological and sterilization standards, as required.
  • Performance management - monitoring of performance indicators relevant to the role.
  • Provide support to site Quality Assurance Manager during external audits of Pall Newquay.

Qualifications/Competencies/Skills:

  • Experience of working within an ISO 13485 / Medical / Pharma / Food.
  • Manufacturing environment.
  • Experience of GMP / GLP.
  • Knowledge and application of the following microbiological and sterilization standards:BS EN ISO 11137-1, BS EN ISO 11137-2, BS EN ISO 11737-1, BS EN ISO 11737-2, BS EN 17141, BS EN ISO 14644-1, BS EN ISO 11135, BS EN ISO 10993-7.

Benefits:

Competitive salary, Life Assurance, 4% ER pension, Annual bonus

*Please note, in order to apply for the role, you must complete the short online application directly via the PALL website using the 'Apply Now' link

Reference: 42832832

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