Job Title
Maintenance and Validation Specialist
About the Role
We are seeking a skilled Maintenance and Validation Specialist to join our team in Wu Xi Biologics Ireland. In this role, you will be responsible for establishing and maintaining our manufacturing systems, ensuring that they meet the highest standards of quality and regulatory compliance.
Key Responsibilities
* Provide expert support to the manufacturing team in areas such as SAP, LIMS, finite scheduling, and benchtop equipment qualification and operation.
* Process and system owner for Manufacturing benchtop equipment, managing vendors, maintaining an accurate equipment list, and ensuring required system SOPs are in place.
* Collaborate with relevant departments on all aspects of benchtop equipment qualification lifecycle (URS to decommissioning).
* Coordinate vendor visits on site for bench top support, qualification, and maintenance as needed.
* Provide input to budget for systems and collaborate with MT and MSAT groups on technical transfer and process validation.
* Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
Requirements
* Bachelor's degree or higher in Chemical Engineering, Bioscience, Biotechnology, or Analytical Science.
* More than 2 years' experience in biopharmaceutical manufacturing, with expertise in GMP systems, including SAP and benchtop equipment qualification and operation.
* Demonstrated ability to work effectively with cross-functional teams, communicate complex information clearly, and adapt to changing priorities and deadlines.
* Proficiency in operating a drug substance commercial manufacturing facility and/or a pilot plant, with knowledge of DQ, FAT, SAT, IQ, OQ, and PQ commissioning and qualification processes.
Benefits
* Bonus scheme based on performance.
* Comprehensive pension scheme.
* Access to on-site canteen and gym facilities.
About Us
We are a world-class biologics services provider dedicated to accelerating and transforming discovery, development, and manufacturing in the biopharmaceutical industry. Our mission is to benefit patients worldwide by providing innovative solutions and exceptional service.
Get Involved
We welcome applications from motivated professionals who share our vision and values. Apply now and discover your true potential.