Senior Engineer, Drug Product

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since 1997, BioMarin has applied scientific expertise to understand the underlying causes of genetic conditions to create transformative medicines using a number of treatment modalities. BioMarin develops medicines for patients with significant unmet medical need, leveraging genetics and molecular biology to pursue bold, innovative science. BioMarin's Technical Operations group is responsible for creating drugs for use in clinical trials and for scaling production for the commercial market. These engineers, technicians, scientists and support staff build and maintain manufacturing processes and sites, provide quality assurance and quality control to meet regulatory standards, and procure goods and services to support manufacturing and the worldwide movement of drugs to patients.

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

Closing Date: 30th July

Technical Development are hiring a Senior Engineer with the following 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.

• 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.

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

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.