Microbiologist

We are seeking to recruit an experienced Microbiologist for our client in Sligo
Description:
Provide microbiological support to the site, ensuring facility and process sterility programme compliance to in-house, corporate and regulatory requirements.
Key Responsibilities:

• Monitor and control the microbial aspects of the Quality System at the Site.


• Operational microbiological support of environmental monitoring, facility / equipment cleaning and clean utilities.


• Microbiology related technical support for manufacturing activities, e.g. aseptic technique development.


• Development of microbiological requirements and methods for cleaning, sterilisation, filtration, facility and personnel monitoring etc.


• Review and develop current procedures for all microbial activities


• Develop and implement training programme for all microbial activities.


• Oversight of facility environmental monitoring programme.


• Responsible for sterility assurance aspects of all GMP inspections / audits from global and regulatory bodies.


• Assist in microbiological aspects of internal and external audits as required.


• Assist in microbiological aspects of investigations, change controls , annual product reviews.


• Maintain compliance to cGMP regulations.


• Complete duties in compliances with the Company's Environmental Health and Safety procedures.


• Foster a good working relationship with all departments and uphold the company's Values of Integrity, Excellence and Respect for People.


• Comply with the Company's HR Policies and Code of Business Conduct.


• Competencies:


• Technical / Professional Knowledge - Having achieved a satisfactory level of technical and professional skill or knowledge in position related areas, keep up with current developments and trends in areas of expertise.


• Continuous Learning - Actively identify new areas for learning and take advantage of all learning opportunities. Apply new knowledge and skills gained in daily activities and learn through their application.


• Planning and Organizing - Establish courses of action for self and others to ensure that work is completed efficiently.


• Safety Awareness - At all times be aware of conditions that affect employee and product safety.


• Work Standards - Set high standards of performance for self and others; assume responsibility and accountability for successfully completing assignments or tasks and self impose standards of excellence rather than having standards imposed.

Experience and Knowledge:
Essential

• Degree (Hons) qualified in microbiology


• 3/5 years post qualification experience in industry ideally in a similar role.


• Experience in FMEA and QRM


• Experience in IMB/FDA audit participation


• Ability to co-operate and work well with others in the pursuit of team goals

Desired

• Experience in fermentation technology


• Cleaning validation experience


• Mammalian cell culture experience


• Sterile filling experience


• Autoclave validation experience

If you would like further information you can contact:

Brian Christensen | Tel: +353 (0) 1 685 4747