Technical Services Specialist

Lead technology transfer for sterile fill-finish at the Athlone facility; provide SME-level expertise across commissioning, automation, and manufacturing operations; plan and deliver technology transfer milestones from gap assessments to process qualification; build data packs and monitor performance to drive yield, quality, and throughput improvements; design, execute, and report study protocols with sample reconciliation; lead cross-functional investigations for deviations and implement corrective/preventive actions; steward single-use systems including extractables/leachables assessments to protect product quality and patient safety; author and review process descriptions, validation and strategy documents to withstand regulatory scrutiny; collaborate with Quality, Supply Chain, and Manufacturing to align material availability with transfer timelines; lead change control activities and provide on-the-floor technical support while ensuring EHS and cGMP compliance; support audit readiness and regulatory documentation.