Job Type: Perm
Job ID: JO-1812-12203
Consultant: Karen McHugh
Are you a Microbiologist with extensive testing experience including; Mycoplasma, Sterility testing and Endotoxin testing?
Do you have an interest in leading a team to support manufacturing operations?
Would you like to work for a multinational Biopharmaceutical company with a manufacturing site in Dublin?
Senior Microbiology Analyst - Biotech - Dublin
JobContax is a preferred supplier to one of the world's leading BioPharma companies.
With major capital investment happening in their plant, this is an exciting time to join the team.
The purpose of the role is to oversee the general running of the Microbiology laboratory, Environmental Management and the aseptic technique associated with the manufacture of a biologics product.
Responsible for oversight of the Microbiology laboratory supporting the manufacturing process
Oversee aseptic practices (gowning, monitoring, cleaning and related training).
Perform microbiological testing as required to support operations.
Perform environmental monitoring as required to support operations.
Ensure that the Microbiology laboratory is set up and operates in compliance with current Good Laboratory Practice / Good Manufacturing Practice at all times.
Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations and Global standards.
Develop and maintain excellent communication and collaboration between the Microbiology laboratory and operations.
Training of microbiology analysts
Scheduling of microbiologist work via visual management
Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of all samples.
Oversee the environmental monitoring programme for the facility.
Participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
Oversight of contract testing laboratories associated with microbiological testing
Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence.
Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.
Manage an effective laboratory documentation system.
Prepare and review documents as required.
Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, customer).
Actively lead and support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
Implement and maintain standards of safety to ensure a safe working laboratory.
Ensure that the laboratory is kept clean, tidy and safe at all times.
As required, act as designee for the Plant Microbiologist in their absence.
Participate as required in global project teams relating to Microbiology and wider quality activities.
Degree in Microbiology or other relevant field.
More than 4 years’ experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company
Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Management
Thorough knowledge of GMP and current FDA & EMEA regulations
Knowledge and experience of Lean Laboratories is preferable
Previous experience in setting up a new Microbiology laboratory is desirable
Excellent organisational, communication, interpersonal and report writing skills
Strong Microbiology knowledge, with the ability to act as a Subject Matter Expert
Ability to adapt to changing priorities
Salary ca €45 - 55K per annum
Excellent benefits package...
Performance Related Bonus
Paid Maternity/Paternity Leave
Educational Assistance Programme
Zero Absence Award
Talent & Development Programme
Occupational Health & Wellness Programme
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact Karen by e-mail email@example.com or phone +353-1-7978720
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