Microbiologist

Job Description

Job Title: Microbiologist

Location: Co. Tipperary, onsite

Position: Permanent

Job Summary:

The Microbiologist is responsible for supporting various microbiological and quality assurance programs to ensure compliance with industry standards and regulatory requirements. This role involves the management and execution of contamination control strategies, environmental monitoring, validation programs, and laboratory management, among other duties.

Key Responsibilities:
1. Quality Assurance and Risk Management:
Complete Non-conformance investigations (NOI’s), Non-conformance evaluations (NOE’s), Change Control (CC), Corrective and Preventive Actions (CAPA), Failure Mode and Effects Analysis (FMEA), and Quality Risk Management (QRM).
2. Contamination Control:
Support the implementation and maintenance of Contamination/Biocontamination Control strategies.
3. Environmental Monitoring and Validation Programs:
Support the Environmental Monitoring Program, including the Cleaning Validation (Bioburden) program and the Compressed Air Program.
Support and advise on Contract Laboratory Investigations.
Manage the Microbial Limits Testing (MLT) Validation for various products.
4. Routine Testing and Water Systems Management:
Oversee the management of routine Raw Materials, Finished Goods, Purified Water, and Water for Injection (WFI) Testing programs.
Develop and maintain the site Purified Water/WFI strategy.
5. Laboratory and Equipment Management:
Manage the equipment program for the Microbiology Lab, including requalifications, calibrations, and sanitizations.
Liaise with Contract Microbiology Laboratories and the Global Micro Team.
Participate as a microbiology team member in cross-functional projects, including cleanroom facility qualification.
6. Documentation and Reporting:
Prepare and review Laboratory Procedures, Specifications, and Reports.
Prepare and execute study protocols and Environmental Monitoring trend reports.
7. Audit and Review Participation:
Participate in technical audits, internal audits, and regulatory audits (e.g., HPRA).
Participate in Management Review meetings.
8. Laboratory Set-Up and Personnel Training:
Heavily involved in setting up a new Microbiology Lab and qualifying laboratory equipment in line with relevant compendia.
Oversee the day-to-day running of the microbiology lab.
Train new microbiology personnel.
Participate in creating a new Microbiology Analyst training program.
9. Leadership and Designee Role:
Act as the assigned designee for the Site Microbiologist in their absence.

Qualifications:
Education: Bachelor’s or Master’s degree in Microbiology or a related field.
Experience: Minimum of 4 years of experience in a microbiology laboratory, preferably within the pharmaceutical or biotechnology industry.

Skills:
Strong understanding of microbiological testing, contamination control, and quality assurance principles.
Proficiency in documentation and regulatory compliance.
Excellent communication and leadership skills.
Ability to manage multiple tasks and projects effectively.

Competencies:
Detail-oriented with strong analytical and problem-solving skills.
Ability to work both independently and as part of a team.
Proactive approach to continuous improvement and learning.
Effective time management and organizational skills.

Work Environment:
This position operates in a laboratory setting with standard lab equipment.
Participation in audits and inspections.