Specialist, Sterility Assurance (Microbiology)

Location: Croydon, London, United Kingdom

Company

Medical technology company focused on improving healthcare delivery and helping save and sustain lives.

What you will do

• Deploy and maintain sterility assurance and environmental monitoring programmes across UK and Ireland compounding facilities.
• Provide technical guidance on contamination control strategies, environmental control, microbiological testing, and aseptic practices.
• Support risk assessments, validation and qualification activities, change controls, deviations, complaints, non-conformances, and quality investigations.
• Review environmental monitoring reports, protocols, microbial identification data, trends, alert limits, and quality metrics.
• Support inspection readiness and participate as a technical representative in internal, corporate, and regulatory audits.
• Develop quality documentation, train operational and quality teams, and lead continuous improvement initiatives.

Requirements

• Degree in Microbiology or another Life Sciences discipline with relevant experience.
• At least 3 years of experience implementing environmental control programmes and investigating and correcting out-of-limit results.
• Strong operational experience in aseptic manufacturing, including aseptic technique and microbiological practices.
• Experience with quality improvement and problem-solving methods such as FMEA, DMAIC, and process mapping.
• Experience with critical equipment and process change control, data interpretation, and Lean manufacturing.
• Strong communication, collaboration, critical-thinking, prioritisation, and autonomous working skills.

Nice to have

• Five years of microbiology experience in an aseptic facility.
• Knowledge of risk management tools and Lean Management principles.
• Experience with Environmental Monitoring Management Software.

Culture & Benefits

• Collaborative environment with ownership, accountability, and cross-functional teamwork.
• Competitive total compensation package.
• Professional development opportunities.
• Strong focus on work-life balance.