Senior Engineering Validation Associate
Location Cork, Ireland Workstyle Onsite Only ApplyWho We Are
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 our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Technical Operations
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 Engineering Validation Associate
Shanbally, Cork
Onsite Role
Closing Date: 14th July 2025
Summary Description:
BioMarin are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. The Engineering Validation team support validation activities across drug substance, drug product and secondary packaging operations.
Reporting to the Engineering Validation Team Lead, the Senior Engineering Validation Associate will focus on maintaining the validated state of GMP equipment, facilities, utilities, and systems.
Responsibilities:
- Key Subject Matter Expert (SME) in specific validation discipline(s). Maintains current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin.
- Ensures Engineering Validation BioMarin maintains regulatory compliance, in line with industry best-practices in specific validation discipline(s).
- Leads & supports complex investigations, regulatory submissions, specific regulatory queries and agency inspections in SME areas of expertise.
- Responsible for strategy development, project management and regulatory compliance for validation projects. Strategically leads and project manages complex validation projects across a variety of disciplines.
- Responsible for management of internal validation resources during project execution and provision of mentorship and SME support to more junior members of the validation team and cross functional groups as applicable.
- Identifies and leads implementation of improvements to the Engineering validation system's
- Executes Validation activities related to the various Validation disciplines.
- Develops validation plans for specific system implementation projects.
- Support the establishment of site validation policies, through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures.
- Prepare and track to completion any assigned change requests, deviations, quality events and associated CAPAs.
- Other responsibilities as assigned.
Education:
- Bachelor of Sciences degree, or higher, in a technical discipline (engineering, chemical or biological sciences) is required.
Experience:
- 5+ years’ experience in a cGMP regulated manufacturing environment, with exhibited knowledge and proficiency in validation execution.
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, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.