Biotechnology Equipment Maintenance Specialist

Lab Equipment Specialist

This is a challenging role for an experienced Laboratory Equipment Specialist to join our team. The right candidate will have a strong background in laboratory equipment lifecycle management, validation and qualification.

We are looking for a skilled professional who can manage and maintain laboratory equipment, ensuring compliance with cGMP regulations and industry standards.

The ideal candidate will have experience in planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems.

Responsibilities include:

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• Managing laboratory equipment lifecycle, including installation, operation, maintenance and disposal\
• Ensuring compliance with cGMP regulations and industry standards\
• Developing and implementing equipment maintenance schedules\
• Coordinating with vendors for equipment repairs and maintenance\
• Participating in technical project teams to act as a subject matter expert on instrument validation regulations and procedures\
• Supporting and managing the addition of project components to CMMS Maximo\
• Acting as a key contributor and sponsor to Data Integrity Assessments for Lab systems\
• Documenting and reviewing equipment maintenance activities\
• Identifying and reporting equipment failures or issues\
• Collaborating with quality control management to ensure equipment is calibrated and maintained according to schedules\
• Reviewing and updating equipment documentation\
• Maintaining accurate records of equipment maintenance and testing\
• Providing training and support to laboratory staff on equipment usage and maintenance\
• Conducting regular audits to ensure compliance with regulatory requirements\
• Monitoring and controlling costs associated with equipment maintenance and repair\
• Improving laboratory efficiency and productivity by identifying areas for process improvements\
• Developing and maintaining relationships with vendors and contractors\
• Scheduling and coordinating equipment maintenance and repairs\
• Planning and conducting routine calibration, requalification and maintenance of laboratory equipment\
• Reviewing and filing of QC calibration & maintenance documentation\
• Planning, executing and documenting the qualification of new laboratory equipment in a cGMP regulated environment\
• 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\
• Investigating and resolving equipment-related issues\
• Documenting and tracking equipment-related incidents\
• Ensuring data integrity and accuracy in equipment-related documentation\
• Implementing and maintaining change control processes for laboratory equipment\
• Managing and documenting changes to laboratory equipment or procedures\
• Providing input to the development of policies and procedures related to laboratory equipment\
• Staying up-to-date with industry developments and best practices in laboratory equipment management\
• Contributing to the development of business cases for equipment purchases or upgrades\
• Leading or participating in continuous improvement initiatives to enhance laboratory operations\
• Maintaining effective communication with laboratory staff, vendors and other stakeholders\
• Providing leadership and guidance to junior team members\
• Supporting the development of laboratory staff through training and coaching\
• Establishing and maintaining relationships with suppliers and vendors\
• Purchasing and specifying laboratory equipment\
• Managing inventory levels and stockroom organization\
• Managing waste disposal and minimizing environmental impact\
• Complying with relevant legislation and regulations\
• Ensuring all work is performed in accordance with established policies and procedures\
• Report any safety hazards or near misses to management immediately\
• Supports and maintains a positive working environment by demonstrating commitment to teamwork, respect, open communication and diversity\
• Supports and participates in achieving company goals and objectives\\[

Requirements

A bachelor's degree in a science-related field is required.

Minimum 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.

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.

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.