Sterility assurance, contamination control, microbiology

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

• 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

A Sterility Assurance or Microbiology professional with several years of experience supporting sterile pharmaceutical manufacturing. The ideal candidate will have worked within aseptic fill-finish facilities producing injectable products, possess strong contamination control expertise, and have experience supporting remediation or compliance improvement programmes. Candidates with exposure to Annex 1 implementation, environmental monitoring, investigations, and sterile manufacturing quality systems will be particularly attractive.

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.