Senior QC Microbiology Specialist

• Duration: 11 months
• Location: Carlow

• Provide technical support to the QC Microbiology Laboratory and site operations

• Support continued manufacture and supply of quality pharmaceutical products

• Contribute to site priorities:

• Compliance

• Supply

• Strategy

• Profit Plan

• Operate at a senior laboratory level with extended responsibilities

• Demonstrate leadership, initiative, and strong decision-making capability

• Collaborate effectively with internal and external stakeholders

• Drive innovation and technical excellence

• Develop and execute microbiology test methods and validation studies

• Troubleshoot validation studies and routine microbiology testing issues

• Execute method and equipment validation activities

• Author and manage:

• Documentation

• Reports

• Change controls

• Procedures

• Test methods

• Deviations

• Authorise microbiological results to support batch release

• Provide microbiological support for site investigations

• Develop and deliver training modules

• Perform bench experiments as required

• Maintain and update LIMS systems

• Assess compendial and quality manual updates relevant to microbiology

• Support environmental monitoring programme:

• Trend analysis

• Corrective and preventative actions

• Support laboratory stock management and financial control

• Drive continuous improvement initiatives (e.g., lean lab, method optimisation)

• Ensure compliance with regulatory and compendial requirements

• Maintain high safety standards

• Perform additional duties as required

• Strong planning and organisational skills

• Excellent written and verbal communication skills

• Strong interpersonal and collaboration skills

• Ability to work within a high-performance team

• Ability to work to deadlines and under pressure

• Strong IT and software proficiency

• Commercial awareness with integrity and professionalism

• High level of initiative, motivation, and drive

• Presentation skills

• Problem-solving and decision-making capability

• Bachelor's degree or higher (ideally in Microbiology or related discipline)

• Minimum 5 years' experience in pharmaceutical microbiology or similar regulated environment

• Strong experience in:

• Bioburden testing

• Endotoxin testing

• Sterility testing

• Method development and validation

• Demonstrated experience in change management and continuous improvement

Morgan McKinley