Sterility Assurance Microbiologist — Contamination Lead (6M, Ireland)

EPM Scientific; Dublin; On-site; EUR 47,000 - 60,000; Full time

Benefits offered by this job

Restaurant d'entreprise

Indemnités de stage/alternance

Job summary

EPM Scientific, Ireland, is seeking an experienced Sterility Assurance Microbiologist to support a major remediation program at a sterile fill-finish facility. You will strengthen contamination control practices and ensure compliance across aseptic manufacturing operations, focusing on vials and pre-filled syringes.

Key duties include supporting environmental monitoring investigations, reviewing GMP documentation, and aligning procedures with Annex 1.

Qualifications

• Degree in Microbiology or related discipline.
• Experience in sterile pharmaceutical manufacturing.
• Strong knowledge of EU GMP, including Annex 1.
• Experience in remediation or compliance projects is desirable.
• Excellent communication and cross-functional teamwork skills.

Responsibilities

• Support site-wide sterility assurance and contamination control activities.
• Provide microbiological expertise for remediation projects and compliance initiatives.
• Review aseptic processing practices across sterile manufacturing areas.
• Support investigations relating to environmental monitoring, sterility, and contamination events.
• Contribute to development of contamination control strategies.
• Review GMP documentation to ensure regulatory alignment.
• Assist with Annex 1 implementation and best practices.
• Collaborate with Quality, Manufacturing, Engineering, and Validation teams to drive remediation actions.
• Participate in root cause investigations and CAPA development.
• Assist with inspection readiness and regulatory improvements.

Skills

Sterility assurance

Microbiology

Contamination control

Aseptic processing

Investigations

Stakeholder management

Cross-functional teamwork

Communication skills

Education

Degree in Microbiology

Biological Sciences

Job description

EPM Scientific, Ireland, is seeking an experienced Sterility Assurance Microbiologist to support a major remediation program at a sterile fill-finish facility. You will strengthen contamination control practices and ensure compliance across aseptic manufacturing operations, focusing on vials and pre-filled syringes.

Key duties include supporting environmental monitoring investigations, reviewing GMP documentation, and aligning procedures with Annex 1.