Thermal Systems Validation Lead

  • Athlone
  • Alexion
Position SummaryThe Thermal Systems Validation Lead has primary responsibility in supporting the Validation activities for Thermal Systems (Steam Autoclaves, Depyrogenation Tunnels, VHP, Controlled Temperature Units (CTUs)) that support the cGMP manufacture of Drug Product at Alexion’s facility in Athlone. The Thermal Systems Lead will provide Thermal Systems Validation expertise to support routine commercial manufacturing and technology transfer Drug product (DP) manufacturing processes in Athlone Facility. The person will be required to work in close collaboration with Operations, Engineering, Quality, Quality Control, Regulatory and other involved departments to provide successful qualification of relevant Thermal systems. The person should have experience in validation of Steam Autoclaves, Depyrogenation Tunnels, VHP Cycles and CTU qualification for relevant production equipment and have the ability to apply SME support on qualification of these systems. The person should have experience in presenting and defending validation strategies during regulatory inspections. In addition, the person will be required to lead and mentor a team of Thermal Systems Validation engineers.Principal ResponsibilitiesTo provide SME validation expertise on Thermal Systems production support equipment: including Stem Sterilisation, Depyrogenation Tunnels, VHP cycles, SIP cycles and CTUs.Lead and Mentor a team of Thermal Systems validation engineers.To author and review validation related documentation, gap assessments, technical protocols and reports, and validation strategy documentsMaintain/update to the validation master plan and any associated related documentation to support the multi-product manufacturing facilities at AthloneTo identify and implement validation process improvements, e.g., Equipment Upgrades, Reducing Validation frequency requirements etc.To generate documentation protocols and lead the execution of plant supporting studies and technical studies on the manufacturing floor at commercial scaleTo provide on the floor support for troubleshooting validation related issues and to lead manufacturing investigations into related deviations and resolutionLead any key Validation related changes using the change control systemAdherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigationsTo author and review technical documents relating to validation activities for SOP’s, Recipe Configuration Specifications.You will need to have:Minimum 7+ years’ experience in Validation or Manufacturing in a biological drug product manufacturing organization.Excellent Technical and operational knowledge of Steam Sterilisation and Depyrogenation Tunnels.Good technical knowledge of refrigeration systems and AHU controlled environments an advantage.Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.Excellent Knowledge of EN285 Sterilisation - Stem SterilisersGood interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization and in local group settingsAbility to present and defend technical and scientific approaches in both written and verbal formAbility to drive for results independently and adapt to rapidly changing prioritiesExperience in cleaning validation and cleaning approaches to a multiproduct facility is advantageousDetail orientatedTechnical writing competencyDate Posted13-Feb-2024Closing Date30-Mar-2024