15168836-QC Lab Support Validation Engineer – Athlone Contractor

This is an initial 6-month contract.

Purpose:

The successful applicant will oversee the routine equipment maintenance and provide laboratory equipment maintenance to the QC Microbiological and Chemistry laboratories to support the advancement of new QC technologies and facilitate new product introduction.

Responsibilities:

• Manage routine laboratory equipment maintenance, qualification, and periodic review
• Schedule and oversee vendors responsible for lab equipment maintenance/calibration
• Support troubleshooting of instrumentation/equipment issues in the lab
• Act as a lab systems administrator for all QC Laboratory Systems/equipment
• Planning and conducting routine calibrations and maintenance of lab equipment where required
• Support the introduction of new QC equipment requiring the planning, executing, and documenting the qualification of new lab equipment in a cGMP regulated environment.
• Generate IQ/OQ & PQ equipment validation protocols and associated reports.
• Ensuring high cGMP, GLP standards are maintained and adherence to schedules and targets to meet regulatory and business requirements.
• Evaluate systems/equipment in accordance with cGMPs, Part 11 & other regulatory requirements
• Generation and resolution of protocol discrepancies and deviations as required.
• Ensure all equipment-related QC Procedures and other GMP documentation are implemented and continuously maintained in a compliant and inspection-ready manner.
• Proactively engage with stakeholders and routinely present project progress updates to senior QC management.

Minimum Qualifications & Requirements:

• Minimum of 7 years of laboratory experience in a cGMP laboratory and instrument validation experience is desirable
• Knowledge of the methodology and instrumentation and analytical techniques used for biopharmaceutical testing.
• In-depth understanding of current regulatory requirements for cGMP laboratory equipment validation and calibration
• Excellent technical competency in the field of instrumentation and equipment validation.
• Skilled in organisation, planning, priority setting, and time management.
• Works in a collaborative manner and is able to develop excellent working relationships with peers.
• Excellent report writing skills.
• Takes a structured, analytical approach to problem-solving
• BSC Degree in Engineering or Science-related subjects.