Elusav Recruitment have a excellent opportunity for a Senior Engineer with sterile drug product experience to join the technical development and operations team of a cutting-edge pharmaceuticals manufacturer specialising in treating rare illnesses. The Senior Engineer will act as a technical SME for drug product commercial production in multiple forms (Lyo, PFS and Vial). Provide commercial support to Quality and Operations departments with niche challenges using specialised knowledge and expertise. Responsibilities: Technical SME for drug product (DP) supporting filling operations, working in a matrix team environment with process development, QA, QC, analytical sciences, packaging, supply chain, and regulatory teams to achieve project objectives. Supporting both Global External Operations (GEO) teams. Develop process comparisons, risk assessments, manage DP technical and manufacturing risks and identify appropriate mitigations. Author technical reports to support DP process and product characterisation. Manage change control, deviations, and CAPAs through the quality management system until closure. Facilitate investigations, root cause analysis for deviation resolution, data gathering/analysis, and provide technical assessments for deviations. Initiate and lead process improvement projects, involving cross-functional teams. Support the technical delivery of new product introductions and tech transfer projects by closely collaborating with cross-functional project teams, ensuring compliance with specifications, regulatory guidelines, and right-first-time delivery. Assist with PPQ campaign readiness and provide in-person, on-the-floor execution support for technical runs and PPQ campaigns as required. Support on-site implementation of changes and DP launch activities. Support aseptic filling operations (vials and pre-filled syringes) for technology transfers and life cycle management, overseeing new product introductions from development batches to approval and commercialization. Assist with regulatory inspections and present technical topics related to process aspects of assigned products when necessary. Ensure a thorough understanding of all quality policies and system items as outlined in the training curriculum. Requirements: Strong understanding and hands on experience in MSAT or process development or technology transfer, background in large scale processing of biologic drug products. Possess a strong understanding and hands-on experience in MSAT, process development, or technology transfer, with a background in large-scale processing of biologic drug products. Have a solid understanding of regulatory requirements and guidelines. Proficient in technical writing. Demonstrated ability to build strong partnerships and work effectively with diverse team members in a dynamic environment. Able to work on the manufacturing floor for extended periods during the execution of technical protocols. A degree in engineering or science with relevant experience in the biotech/pharmaceutical field. Contact: If you would like to learn more about the vacancy, apply now, or contact Stephen O'Brien on or. Skills: Pharma GMP Engineering