Quality Control Microbiologist

Morgan McKinley; Athlone; On-site; EUR 50,000 - 70,000; Full time

Job summary

Morgan McKinley is seeking an experienced QC Microbiology Specialist to join a GMP-regulated pharmaceutical manufacturing environment in Athlone, Ireland. The role supports environmental monitoring, water testing and microbiological testing of raw materials and in-process samples, and executes validation and qualification activities.

This hands-on position sits in a quality control microbiology laboratory supporting sterile manufacturing operations and ensuring compliance with current GMP and

Qualifications

• Minimum 5 years' experience within a cGMP Quality Control Microbiology laboratory environment.
• Experience with environmental monitoring, water testing and microbiological testing of materials and samples.
• Experience with sterile manufacturing operations and regulatory GMP expectations.
• Experience performing validation and qualification activities.
• Strong attention to documentation and data integrity.

Responsibilities

• Support environmental monitoring and microbiological testing including endotoxin, bioburden and related assays.
• Perform water testing and associated microbiological testing.
• Execute validation and qualification activities for processes and analytical methods.
• Review data and documentation to ensure accuracy and compliance.
• Contribute to development and improvement of site procedures.
• Provide GMP sterility awareness training as needed.
• Carry out routine laboratory maintenance and safety compliance.

Skills

cGMP Microbiology

Environmental monitoring

Sterile manufacturing

Method validation

Data integrity

Documentation

Education

Degree in Microbiology

Job description

We are seeking an experienced QC Microbiology Specialist to join a GMP-regulated pharmaceutical manufacturing environment. The successful candidate will support environmental monitoring, water testing and microbiological testing of raw materials and in-process samples, as well as the execution of validation and qualification activities.

This is a hands-on role within a quality control microbiology laboratory, supporting sterile manufacturing operations and ensuring compliance with current GMP and regulatory expectations.

Key Responsibilities

• Work collaboratively with Manufacturing, Technical, Quality and other site functions to support shared safety, quality, delivery and cost objectives.
• Maintain a strong focus on health and safety, using appropriate safety procedures, PPE and permits when undertaking sampling or laboratory testing.
• Maintain high standards of laboratory housekeeping and good laboratory practice.
• Perform environmental monitoring, water testing and associated microbiological testing, including endotoxin, bioburden, TOC/conductivity, growth promotion, bacterial identification and biological indicator testing.
• Participate in and, where appropriate, lead laboratory investigations using structured problem-solving techniques.
• Develop laboratory procedures and contribute to the development and improvement of site procedures.
• Execute validation activities, including process and analytical/method validation protocols.
• Review laboratory data, records and documentation to ensure accuracy, completeness and compliance.
• Carry out routine laboratory equipment maintenance and support equipment upkeep.
• Develop and deliver GMP sterility assurance and microbiology awareness training to relevant personnel.
• Participate in periodic media fill studies to support ongoing manufacturing line qualification.
• Ensure batch and laboratory testing documentation is completed accurately and in a timely manner in accordance with cGMP requirements.
• Proactively identify and elevate safety, quality, compliance or performance risks.

Skills & Knowledge

• Practical experience in microbiological testing within a sterile pharmaceutical manufacturing environment, including environmental and utility monitoring.
• Experience with microbiological or analytical method validation.
• Good knowledge of current regulatory and GMP requirements relating to microbiology and sterility assurance.
• Experience working within a Quality Risk Management framework.
• Strong attention to detail, documentation and data integrity.
• Ability to work effectively both independently and as part of a cross-functional team.

Education

• Degree in Microbiology or a closely related scientific discipline.

Experience

• Minimum 5 years' experience within a cGMP Quality Control Microbiology laboratory environment.
• Ideally, a minimum of 2 years' experience within the pharmaceutical industry.
• Experience supporting sterile manufacturing operations would be highly desirable.

Working Environment & Physical Requirements

This is a hands-on laboratory and manufacturing support role with a level of physical activity associated with environmental monitoring, cleanroom sampling and laboratory testing, including work with laboratory isolators and associated equipment.

The role may involve regular standing, walking, reaching and use of hands to operate laboratory equipment and controls. The successful candidate may occasionally be required to lift or move items weighing up to approximately 5 kg and may need to crouch or work in cleanroom environments.

Appropriate protective and safety equipment must be worn as required.

The position is expected to operate primarily on a regular day-shift basis; however, there may be a requirement to work shifts depending on operational needs. Flexibility to work the required shift pattern would therefore be advantageous.

Reasonable adjustments may be considered to enable individuals with disabilities to perform the essential functions of the role.

Travel

Occasional national and international travel may be required for activities such as training, equipment testing or implementation. This is expected to be infrequent and may include overnight stays, with travel anticipated to be up to approximately 10% of the role.