Role Overview

• 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
  
  

Key Responsibilities

• 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
  
  

Experience, Knowledge & Skills

• 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
  
  

Qualifications & Education

• 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