Sterility assurance, contamination control, microbiology
Contract Details
- Location: Ireland
- Duration: 6 Months
- Working Pattern: On-site
- Employment Type: Contract
- Sponsorship: Not available. Candidates must possess full rights to work in Ireland or the European Union.
Overview
We are supporting a leading pharmaceutical manufacturer in Ireland that is undertaking a significant remediation and compliance improvement programme at a sterile fill-finish facility. The site manufactures sterile injectable products, including vials and pre-filled syringes.
This six-month contract offers an opportunity for an experienced Sterility Assurance Microbiologist to play a key role in strengthening contamination control practices, supporting remediation activities, and ensuring compliance across sterile manufacturing operations.
Responsibilities
- Support site-wide sterility assurance and contamination control activities.
- Provide microbiological expertise for remediation projects and compliance initiatives.
- Review and assess aseptic processing practices across sterile manufacturing areas.
- Support investigations relating to environmental monitoring, sterility, and contamination events.
- Contribute to the development and enhancement of contamination control strategies.
- Review procedures, risk assessments, and GMP documentation to ensure alignment with current regulatory expectations.
- Support implementation of Annex 1 requirements and best practices in sterile manufacturing.
- Partner with Quality, Manufacturing, Engineering, and Validation teams to drive remediation actions.
- Participate in root cause investigations, CAPA development, and effectiveness reviews.
- Assist with inspection readiness activities and regulatory compliance improvements.
Requirements
- Degree in Microbiology, Biological Sciences, Biotechnology, Pharmacy, or a related discipline.
- Proven experience within sterile pharmaceutical manufacturing environments.
- Strong background in sterility assurance, microbiology, contamination control, or aseptic processing.
- Experience supporting sterile fill-finish operations involving vials and/or pre-filled syringes.
- Understanding of EU GMP requirements, including Annex 1.
- Experience supporting remediation, quality improvement, or compliance projects is highly desirable.
- Strong investigation, problem-solving, and stakeholder management skills.
- Excellent communication skills and ability to work within cross-functional teams.
Ideal Candidate Profile
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