Senior Associate/associate, Qa Validation

Who We Are Bio Marin 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 Bio Marin'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 Bio Marin'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.
Sr QA Validation Associate/QA Validation Associate Onsite Role - Shanbally, Ringaskiddy, Cork Closing Date: 30th September 2025 Summary Description: Bio Marin are a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.
This position is responsible for the quality oversight of validation activities in a GMP regulated environment, incorporating implementation, requalification and decommissioning of manufacturing processes, equipment, computer systems, laboratory systems and changes to existing equipment.
Responsibilities: Provide quality oversight for FUE activities related to Bio Marin's products and facilities, utilities, equipment (FUE).
Support the development of validation plans for specific system implementation projects.
Supporting and reviewing/approving (project lifecycle documentation (URS, RA, Commissioning, Qualification Protocols)) validation activities related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.
Establish Site Validation Policies, through development, generation and implementation of validation master plans, guideline documents and SOP's.
Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by Bio Marin, validation techniques/approaches and systems utilized at Bio Marin Lead and represent QA Validation in multi-departmental meetings & project teams.
Identifies and implements improvements to the QA Validation systems.
Participation in the change control program for modifications to qualified systems.
Quality oversight for the Revalidation Evaluation program.
Identify, track and resolve issues through robust root cause analysis in a timely manner working with relevant SMEs as required.
Apply a risk management approach to identify, categorize, prioritize, mitigate and establish contingency plans associated with qualification / validation and system risks.
Education: Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
Experience: +3 years' experience in a c GMP regulated manufacturing environment, with knowledge of equipment and utility validation, and laboratory systems / validation.
Organizational and management skills to coordinate multi-discipline project groups Ability to speak, present data, and defend approaches in front of audiences and inspectors Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for equipment validation expectations.
Proficiency with technical summary report generation required, with exceptional organizational, spelling, grammar, and typing skills preferred.
Contacts: This position will require interaction with multiple levels (from technicians up through Sr.
Management) in Engineering, Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Manufacturing Sciences, Facilities, Regulatory Affairs, Accounting, and Human Resources.
Supervisor Responsibilities: There are currently no direct reports to this position.
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.
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