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QA Validation Associate – Business Sustainability

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.



QA Validation Associate – Business Sustainability


SUMMARY DESCRIPTION
BioMarin are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. The QA Validation team support validation activities across drug substance, drug product and secondary packaging operations.

Reporting to the QA Validation Sustainability Team lead, the QA Validation Associate will focus on maintaining the validated state of GMP equipment, facilities, utilities, and systems.

RESPONSIBILITIES

  • Provide project management and / or quality oversight for validation activities.
  • Apply a risk-based approach to validation strategy, ensuring appropriate documentation and approval.
  • Lead and represent QA Validation in multi-departmental meetings & project teams.
  • Establish validation policies, through development, generation and implementation of validation master plans, guideline documents and SOP’s.
  • Execute validation activities, including management; development; execution and reporting of Revalidation Evaluation (RVE), Periodic Review (PRR) and change control programs.
  • Maintain current knowledge of industry standards and regulatory requirements for validation techniques/approaches and systems utilized at BioMarin.
  • Coordinate validation activities involving cross-functional, multi-departmental teams including: Manufacturing, Quality Control, Quality Assurance, and others.
  • Identify and implement improvements to the QA Validation systems.
  • Participate in and lead preparation for regulatory and corporate audits
  • Other responsibilities as assigned.

EDUCATION
Bachelor of Sciences degree, or higher, in a technical discipline (engineering, chemical or biological sciences) is required.


EXPERIENCE

3+ 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.

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.

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Cork

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