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Sterility Assurance Lead

Ref: 78194

  • 55,000-75,000
  • 04 Nov 2022
  • Waterford
  • Permanent

Sterility Assurance Lead

About the Company

An opportunity to join one of the premium employers in the South East and lead Sterility Assurance activities at this diversified manufacturing site.

About the Position

In this role you will provide essential support to the sterile manufacturing areas, working with new innovative technologies and developing and improving aseptic processes for recently qualified aseptic processing area. The team provides support on contamination control strategy and implementation, media fills, major investigations, and program support.

Ideally you will hold a Degree or Masters in Microbiology and bring at least 5 years of experience in Pharma/Biologics.

Key Responsibilities

  • Oversee the development and support for strategies regarding to contamination control, media fill, environmental monitoring, PQs, decontamination, sterilisation, dehydrogenation, and management of sterility breaches.
  • Cleaning validation for microbial properties such as bioburden and endotoxin.
  • Lead sterility assurance investigations.
  • Review and approve documentation related to commissioning, PQs, process validation, risk assessments and regulatory related to sterility assurance.
  • Review specifications for consumables relating to biological indicators and product specifications.
  • Participate in audits and inspections internally and externally based on sterility assurance aspects.
  • Involvement in the introduction of modern technologies.
  • Contribution to programme design, training, and development of new and existing employees.

Experience/Requirements

  • 5+ years’ experience in Pharmaceutical/Biotechnology industry working in aseptic processing.
  • Degree or higher in Microbiology
  • Project and/or operational support in Quality/Validation/Microbiology or Manufacturing within an aseptic manufacturing environment
  • Experience in leadership position is desirable
  • In depth knowledge of EU & FDA regulatory agencies expectations
  • A detailed and complete knowledge of international cGMP
  • Expert knowledge with current international pharmaceutical/biotechnology industry trends

Remuneration Package

A strong salary range is available along with a great package of benefits.
Contact
For more information on the role or any other Engineering or Life Sciences roles call Nigel on 087 3618142 or email me or click the apply button below.
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