Microbiology Laboratory Manager – Co. Kilkenny
- An exciting opportunity has arisen for a Microbiology Laboratory Manager to join as a part of an experienced team designing and setting up a new microbiology and sterilization dose laboratory at our client’s new facility in Co. Kilkenny.
- In this role, as Microbiology Laboratory Manager, The Lead will work with the Technical Services Manager to identify and recruit staff to support a 24/7 manufacturing facility.
- This includes the development and roll out of the necessary training packages to ensure that the area is fully compliant with local and divisional regulations, policies and procedures.
- You will also provide direction for product disposition based on microbiological and sterilisation investigations and results, and maintains awareness of the regulatory environment and emerging microorganisms of concern.
- This function shares responsibility for creating and supporting risk mitigation strategies, continuous improvement initiatives and process improvements.
- The successful candidate provides functional and strategic microbiological leadership and direction in quality and compliance to the site.
Core Duties and Responsibilities:
- Control the activities for the Microbiology testing and in process testing laboratories.
- Provide Facility Microbiological Support. Technical support for facility issues in the areas of sterilization, environmental monitoring, and microbiological methods.
- Direct microbiologists and dosimetry analysts to write protocols and reports for qualifications for sterilization, dosimetry, cleanroom and microbiological test method and equipment validations and provides guidance and feedback.
- Collaborate and liaise with new and existing contract services and suppliers.
- Develop and issue goals, policies, procedures and programs to produce results in accordance with the corporate objectives as well as the objectives of individual customer and departments.
- Determine requirements for new and replacement equipment, providing training and job instruction, knowing safety rules and regulations and making sure all personal are trained on safe work practices.
- Seek out and stay up to date with new techniques, equipment and materials associated with the field.
- Provide expert technical support to direct reports for areas of responsibility.
- Assure that all regulatory requirements are met and maintained to include FDA, GMP, and ISO requirements.
- Coordinate internal and external microbiology and dosimetry testing to ensure accuracy of data and timely communication of results.
- Maintain the organization of the labs, custodian of calibrated instruments, maintaining inventory of supplies, storage and maintenance of test fixtures, and the contact person for released test instructions and training.
- Adhere to general safety rules, manufacturing procedures, company policies and procedures, Good Manufacturing Practices and FDA regulations.
- Share responsibility for all aspects of Quality and Regulatory Compliance necessary to ensure that there is no major disruption of site business due to quality or compliance issues.
- Run the Data analysis of sterilization processes.
- Be accountable for Laboratory personnel safety, quality and on-time delivery. Support lab staff in understanding company policies and practices. Ensure adherence to all ISO and FDA quality regulations.
- Communicate with and listen to lab staff on a daily basis regarding work team performance, strategic initiatives, policy changes, safety, quality, etc. Take notice of process related problems and support lab personnel. Develop and maintain quality management policies and procedures in compliance with external/internal audits.
- Be called on to be a subject matter expert when working with the FDA of other regulatory agencies.
Education & Qualifications Required:
- Relevant third level Degree in Science or equivalent.
- Minimum 5 years in the Scientific or equivalent.
- Experience with ISO cleanrooms, sterilisation, dosimetry, bioburden testing and endotoxin testing is preferred.
- Experience in developing projects or sites from square one would be a big advantage.
To Apply: Quote – PE23063
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, R95 F727, Ireland.
+353 56 77 90100
Please note, we do not require agency assistance with this role.