Senior Engineer, Drug Product

Senior Engineer, Drug Product - BioMarin Pharmaceutical Inc.

Biomarins Technical Operations group creates drugs for clinical trials and scales production for the commercial market. Engineers, technicians, scientists and support staff build and maintain manufacturing processes, provide quality assurance and quality control to meet regulatory standards, and procure goods and services to support manufacturing and distribution of drugs to patients.

• 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.
• Support both Global External Operations (GEO) and Shanbally teams.
• Develop process comparisons, perform 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 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, with background in large-scale processing of biologic drug products.
• Solid understanding of regulatory requirements and guidelines.
• Proficient in technical writing and in MS Office tools (Word, Excel, Outlook, PowerPoint, MS Project).
• Demonstrated ability to build strong partnerships and work effectively with diverse teams in a dynamic environment.
• Excellent organizational, interpersonal communication, and problem-solving skills.
• Ability to identify, communicate, and implement continuous process improvements and manage tight timelines.
• Willingness to work on the manufacturing floor for extended periods during the execution of technical protocols.
• Strong written, verbal, and presentation communication skills; sound judgment and effective decision-making; ability to balance priorities across multiple stakeholders.

• 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.

• Mid-Senior level

• Full-time

• Manufacturing

• Biotechnology Research and Pharmaceutical Manufacturing