Technical Operations Specialist

Technical Operations Specialist (25_25) Terumo BCT is a Global leader in blood management, blood safety, therapeutic apheresis, cell therapy and cell collections. We have an exciting opportunity for a Technical Operations Specialist to join Terumo BCT- Larne. Come join us today! The successful candidate this role plays a key part in executing technical documentation, QMS activities, and operational improvement initiatives that drive safety, quality, compliance, and efficiency. This position will work closely with cross-functional teams including Production, Quality Assurance, and Engineering to support GMP operations, maintain high standards of documentation, and ensure timely resolution of non-conformances and technical issues. Key Responsibilities Process Support: Provide technical support to commercial manufacturing processes, including Non-conformance (NCs) by supporting root cause analysis, and implementing corrective/preventive actions (CAPAs). Change Notice (CN) and Variance Documentation ownership to support process changes within the manufacturing environment. Technology Transfer: Support the transfer of new products or processes from R&D or external partners to commercial manufacturing, including development of process documentation, training materials, and execution plans. Process Improvement: Lead or support continuous improvement initiatives to increase efficiency, reduce variability, and enhance product quality using tools such as Lean, Six Sigma.Implement new processes or equipment to support the continuous advancement of manufacturing operations. This includes assessing current production capabilities and identifying areas where technological upgrades or process redesigns can lead to increased throughput, reduced costs, improved safety, or enhanced product quality. Documentation & Compliance: Author and review technical protocols, reports, SOPs, and batch records in compliance with GMP and regulatory guidelines. Ensure data integrity and audit readiness. Provide ownership for all manufacturing QMS (Windchill) activities and maintain technical logs and trackers. Data Analysis: Analyse process data and trends to identify performance improvements, using statistical tools to support decision-making. Contribute to the development of KPIs and performance dashboards. Team Collaboration: Work closely with Quality Assurance, Quality Control, Engineering, and Supply Chain to ensure smooth and compliant operations. Act as a Subject Matter Expert (SME) forGMP, QMS, and Process Improvement tools, ensuring the manufacturing team are trained and supported in these areas. Uphold site safety, quality, and compliance standards. Education Bachelors degree in life sciences, engineering, or pharmaceutical-related field. Experience Solid foundational experience in a GMP-regulated pharmaceutical, medical device, or similarly regulated industry, with demonstrated familiarity in working within strict compliance and quality standards Skills Demonstrated skills in Process Improvement Excellent written and verbal communication skills, including the ability to prepare technical reports and interact with cross-functional teams Strong analytical and problem-solving skills with the ability to interpret data and propose effective solutions Additional Information This is an on-site role, based at our Larne facility. If you're ready to make a significant impact in a dynamic and collaborative environment, we invite you to apply for this exciting opportunity. Please submit your CV viaour Terumo BCT careers portal mySource before the closing date of5:00 pm on Thursday, 17 July 2025. You must clearly demonstrate on your CV / application how you meet the required criteria as failure to do so may result in you not being shortlisted. Join us in driving progress and supporting patients locally and across the globe every day by Contributing to Society Through Healthcare! Skills: Process Improvement Technical Reporting Strong Analytic Skills Problem Solving Date Interpretation Benefits: Healthcare Cash Plan Competitive Salary Attractive Annual Leave Pension Plan Performance Bonus Income Protection Life Assurance