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Shipping & CMO Process Validation Associate

Location Cork, Ireland


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. Come join our team and make a meaningful impact on patients’ lives.

In Ireland, BioMarin operates aBiopharma Manufacturing Site in Shanbally, Co. Cork, and a Global Commercial Operations Hub in Dublin.

What makes working here unique? At BioMarin, we feel the intense tie between the work we do and the life-changing results it delivers. Our focus on rare disease gives us the rare opportunity to truly impact lives.As BioMarin employees, we’re here because we want to be here. We enjoy our work — and each other. Our people are smart. Unassuming. Collaborative. Curious. Interesting. In return, there is development, empowerment and total reward.

Role Summary

BioMarin is 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 organisational skills.

This position is responsible for the execution, review and approval of validation activities in a GMP regulated environment, focused on implementation of new packagingequipment and processes, shipping configurations, and changes to existing equipment/processes.

Role Responsibilities

  • Provide project management oversight for validation activities, throughout the validation life-cycle across a broad range of validation disciplines including, but not limited to:
    • New & modified Facilities, Utilities & Equipment (FUE)
    • Drug Product Process Validation at CMO facilities
    • Packaging Process Validation at CMO facilities
    • Shipping Qualification
  • Develop validation plans for specific system implementation projects.
  • Execute (protocol generation, execution, and final package preparation) validation activities related to the implementation of changes to validated systems and processes while exercising judgment within broadly defined procedures and practices to establish approval criteria and identify and implement solutions.
  • Establish Global 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 BioMarin, validation techniques/approaches and systems utilised at BioMarin.
  • Lead and represent Validation in multi-departmental meetings & project teams.
  • Identify and implement improvements to the Global Validation systems.
  • Participation in the change control program for modifications to qualified systems.
  • Coordinate Validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, Supply Chain Logistics, Planning and others.
  • Participate in development and implementation of global alignment projects with BioMarin’s sister sites.
  • Other duties as assigned.

EducationRequired

  • Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is preferred.

Experience Required

  • Twoyears’ experience in a cGMP regulated manufacturing environment, with experienceof equipment qualification and process validation.
  • Demonstrated proficiency in some or all of the listed Validation disciplines would be an advantage.
  • Organisational 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 organisational, spelling, grammar, and typing skills preferred.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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