Senior Associate/Associate, QA Validation
Location: Shanbally, Ringaskiddy, Cork (Onsite). Closing Date: 30th September 2025.
Overview
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 its founding in 1997, the company has applied its expertise in genetics and molecular biology to create transformative medicines, developing a diverse pipeline of candidates with substantial unmet medical need.
About Technical Operations
BioMarin’s Technical Operations group is responsible for creating drugs for clinical trials and scaling production for the commercial market. Engineers, technicians, scientists and support staff build and maintain cutting‑edge manufacturing processes and sites, provide quality assurance and quality control, and procure the goods and services needed to support manufacturing and coordination of worldwide movement of drugs to patients.
Responsibilities
* Provide quality oversight for FUE activities related to BioMarin’s products and facilities, utilities, equipment.
* Support the development of validation plans for specific system implementation projects.
* Review and approve project lifecycle documentation (URS, RA, commissioning, qualification protocols) related to the implementation of facilities, utilities, equipment changes while exercising judgment within broadly defined procedures and practices.
* Establish site validation policies, develop, generate and implement validation master plans, guideline documents and SOPs.
* Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, including validation techniques/approaches and systems utilized.
* Lead and represent QA Validation in multi‑departmental meetings and project teams.
* Identify and implement improvements to the QA Validation systems.
* Participate in the change control program for modifications to qualified systems.
* Conduct quality oversight for the re‑validation evaluation program.
* Identify, track and resolve issues through robust root cause analysis, applying a risk management approach to 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 cGMP 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.
* Comprehension of 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, with exceptional organizational, spelling, grammar and typing skills preferred.
Contacts
* Interaction with multiple levels from technicians up through senior management in Engineering, Quality Assurance, Quality Control, Corporate Compliance, Manufacturing, Manufacturing Sciences, Facilities, Regulatory Affairs, Accounting, and Human Resources.
Supervisor Responsibilities
* No direct reports currently.
Other Information
Seniority Level: Mid‑Senior level
Employment Type: Full‑time
Job Function: Quality Assurance
Industry: Biotechnology Research and Pharmaceutical Manufacturing
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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