Senior Engineer, Drug Product

Senior Engineer, Drug Product

BioMarin

Cork, Ireland

Duties

• 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) and Shanbally 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 BioMarin system items as outlined in the training curriculum;
• Other duties as assigned.

Skills

• 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;
• Excellent organizational, interpersonal communication, and problem-solving skills;
• Capable of identifying, communicating, and implementing continuous process improvements;
• Ability to multi-task and manage tight timelines in a fast-paced environment;
• Able to work on the manufacturing floor for extended periods during the execution of technical protocols;
• Excellent written, verbal, and presentation communication skills;
• Strong analytical skills and sound judgment;
• Effective decision-making skills, with the ability to negotiate and balance decisions and priorities across multiple stakeholders' needs;
• Proficient in MS Office: Word, Excel, Outlook, PowerPoint, MS Project, etc.

Education and experience

• A degree in engineering or science with relevant experience in the biotech/pharmaceutical field.