Biotech QC Specialist CMMS Maximo

Biotech QC Specialist CMMS Maximo, Dun Laoghaire, Dublin

Office/Project Location:Dun Laoghaire, Dublin

Employment Type: Contract

Work Location:  On Site

Pay: €35 - €45 per hour

Experience: 3+ years

Visa: EU passport or Stamp 4 visa required

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin. 

The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. 

This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

Responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at Dun Laoghaire.

Responsible for ensuring that all maintenance & calibration activities carried out by Calibration Technicians are tracked & managed through the Computerised Maintenance Management System (CMMS) Maximo.

Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility for Data Integrity testing and business administration of Laboratory Computer Related systems.

Responsible for the execution of protocols once approved.

Planning and conducting routine calibration, requalification and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo. Reviewing & filing of QC calibration & maintenance documentation.

Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment, including the writing of equipment validation protocols and associated summary reports.

Conduct periodic reviews of instrument validation as part of validation life cycle.

Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required

Scheduling and coordination of equipment repairs and maintenance with vendors/contractors, while minimizing level of down-time for lab equipment, and disruption to laboratory activities.

Participation in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.

Where applicable, owns and project manages change controls and adherence to Change Control metrics

Supporting and managing the addition of project components to CMMA Maximo

Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems

Requirements

Bachelor's degree in a Science related field is required.

Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.

Candidate should have specific hands-on laboratory equipment lifecycle and validation experience.

Candidates should have direct involvement in equipment quality installation or maintenance programs. This goes beyond simple data entry or using Excel spreadsheets—candidates must demonstrate experience coordinating proactive, prevention-focused maintenance schedules, and collaborating with vendors for onsite support. 

A key aspect of this role includes thorough document review related to maintenance activities.

Ideal candidates have a proven track record of assessing equipment integrity through periodic validation and challenge testing, ensuring ongoing compliance. 

Experience in computer system validation (CSV) or equivalent is highly valued, especially for those who have managed or reviewed revalidation cycles to determine if further work is necessary.

Strong familiarity with relevant computer applications is essential, enabling candidates to efficiently manage documentation, reporting, and data analysis tasks.

Demonstrated experience in change control processes is critical. 

Candidates should be able to manage and document changes to equipment, procedures, or systems while ensuring regulatory compliance and operational continuity.

Detailed knowledge of the methodology, and instrumentation and analytical techniques used for biopharmaceutical testing.

Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.

Demonstrated success in managing an equipment qualification or maintenance program advantageous.

Package

Contract role - Hourly rate €35 - €45 per hour

Minimum 12 month contract

Shift Patterns: No

OT/DT: Yes

Onsite Requirements: 

Onsite expectations are 3 days per week. 

Typically, there is at least one team member onsite every day of the week. 

However, the need for onsite presence can be determined on business activities which could result in the need for the CW to be onsite 5 days a week on occasions.