Senior Engineer, Drug Product Technology Transfer
Description
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.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
Senior Engineer, Drug Product Technology Transfer - Shanbally, Ringaskiddy, Cork (Hybrid)
Technical Development are hiring a Senior Engineer with the following duties:
Duties
Duties
- Support technical delivery of NPI and TT projects through close collaboration with cross functional project teams, ensuring compliance with specifications, regulatory guidelines, and right first-time delivery.
- Represent as the technical SME for Drug Product filling operations and build strong partnerships within the BioMarin Network in a matrix team environment.
- Key team member to oversee new product introductions at the BioMarin Shanbally site, from development batches to approval and commercialization.
- Support aseptic filling operations (vials and pre-filled syringes) for technology transfers and life cycle management.
- Lead risk assessments in support of product(s) technology transfers.
- Develop data driven strategies for process development / product characterisation.
- Author technical reports to support Drug Product Technology Transfer and Drug Product Process and Product Characterization.
- Develop design of experiments for execution of lab studies/analytical work with a high level of autonomy.
- Own change control, deviations, and CAPAs until closure, through the quality management system as needed.
- Support on-site implementation of changes and Drug Product launch activities.
- Support investigations, facilitate root cause analysis for deviation resolution, data gathering/analysis, and provide technical assessments for deviations.
- Assist PPQ Campaign readiness and in-person, on the floor execution support for Technical runs and PPQ campaigns.
- Initiate and lead process improvement projects, involving cross-functional teams.
- Author CMC sections of US and international regulatory dossiers, draft responses to the heath agency requests during health agency review.
- Support regulatory inspections and present technical topics during inspections for process-related aspects of assigned products when necessary.
- Support development of Drug Product global technical policies, standards, and guidelines as needed.
- Ensure personal understanding of all quality policy/BioMarin system items that are per training curriculums.
- Other duties as assigned.
Skills
- A degree in engineering or science with a minimum 5 years of relevant experience in biotech/pharmaceutical field.
- Strong understanding and hands on experience in MSAT or process development or technology transfer, background in large scale processing of biologic drug products.
- Understanding of regulatory requirements and guidelines.
- Proficient in technical writing is needed.
- Team player with demonstrated skills of building strong partnerships and working with diverse team members in a dynamic environment.
- Excellent organizational, interpersonal communication, and problem-solving skills.
- Ability to find, communicate, and implement ways to continuously improve processes.
- Ability to multi-task and manage tight timelines in a fast paced environment.
- Ability to work on the manufacturing floor for extended period during execution of technical protocols.
- Excellent written, verbal, and presentation communication skills.
- Demonstrated strong analytical skills and judgment.
- Effective decision-making skills – ability to negotiate and balance decisions and priorities across needs of multiple stakeholders.
- Proficient in MS Office: Word, Excel, Outlook, PowerPoint, MS Project etc.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.