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Microbiology Manager

Cranleigh Scientific
Job LocationKent
EducationNot Mentioned
Salary£55,000 - £60,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

A leading medical device manufacturer has an exciting opportunity for a Microbiology Manager to join its team. You will be responsible for the overall management of the Microbiology Lab with 5 direct reports. To be considered, you must have strong knowledge in sterilization and microbiology processes. You will also need to have previous experience of leading a team and lab.Job Summary:You are responsible for the overall management of the Microbiology Lab. Actively participate and be accountable of QA Sterilization activities and projects in order to assure but not limited to QSR, MDSAP, GMP, and GLP compliance.

  • Ensures the Microbiology Lab maintain good working practices and procedures in accordance with the principles of cGMP (current good manufacturing practices) and GLP (Good Laboratory Practice).
  • Ensure the lab remains compliant with the requirements of the relevant international standards and method validation status is maintained to support product manufacture, testing and release.
  • Oversees the smooth running of the Microbiology Lab and to deliver data to the Quality department in a timely manner to facilitate the disposition of finished products.
  • Advise and support on sterilization process requirements, validation and requalification, of gamma and E- Beam irradiation, locally and globally, to assure compliance and strengthening of Sterilization Program.
  • Work with Vendors to ensure compliance to relevant standards of external origin.
  • Participant and/or lead in External Audits of Sterilization and Microbiology vendors
  • Interaction with Notifiable Body requests and changes relating to sterilization and microbiology, including audits by regulators and customers.
  • Developing methods and procedures for new processes, new technologies and new vendors
  • Is responsible updating policies and procedures for the function and advising managers at all levels with regards to the content.
  • Provide SME input into site/business development activities, such as new equipment design and installation
  • Liaises with the Supply Chain Department regarding the facilitation of finished product release and resolve any issues which impact on the final release date.
  • Acts as site SME for Microbiology & provide support during internal/external audits as and when required. Overall responsibility for liaising with managers and stakeholders to ensuring the safety of the product to be fit for purpose
  • Provides testing resource for product development and ongoing product support for the product technical files and regulatory documentation.
  • Responsible for ensuring constant supply of consumables are procured in a timely manner and to set budgets. Assists the budget holder in determining usage of consumables each year.
  • Provides visibility of the performance of the cleanrooms and filling lines through monthly reporting of core KPIs.
  • Provides technical knowledge of environmental controls and monitoring systems to facilitate internal investigations including CAPA, Non-Conformances and Deviations
  • Maintains, revises and reports on primary component manufacturing bioburden and sterilization validation performance (ISO11137 programme).
  • Controls the release of product from a Microbiology perspective via the signing of Sterility Release Certificates.
  • Ensures the training of the Microbiology Lab personnel is maintained and Personal Development Plans are in place
  • Ensures that the Microbiology team have set objectives and goal in line with the business strategy, and accountable for delivery.
  • Responsible for managing & supervising external contractors relating to microbiology practices
  • Assesses department resources and responsible for Hiring personnel to ensure smooth operation of the department.
    • Qualifications & Experience
  • Experience in managing a cGMP/GLP Laboratory.
  • Strong experience in sterilization process, specifically irradiation, and ideally aseptic processing & controls
  • Application of relevant ISO, FDA & EU regulations
  • Experience in writing technical reports.
  • Experience of working within a Medical Device or Pharmaceutical manufacturing facility.
  • Experience in planning & coordinating an ISO classified room validation.
  • Experience in planning, conducting, and reporting on investigations of microbial contamination of controlled environments and products.
  • Internal and external audits, acting as SME, hosting visitors within a lab environment.
  • 2 years experience of Managing People
  • Educated to scientific degree level in Microbiology or have equivalent professional experience and / or qualification
  • Ideally the candidate will have one or more of the following professional qualifications or licenses
  • Quality Auditor Certification
  • Affiliation to the Institute of Quality Assurance
  • Membership to a professional body associated with their scientific degree
  • Bachelors degree in a microbiology or science
    • Required skills
  • Medical Device - ISO 13485 - Aseptic - Sterile

    • Keyskills :
    Medical Device - ISO 13485 - Aseptic - Sterile

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