QA Validation Specialist/ Associate
Who We Are
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
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 - Shanbally, Cork
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.
- 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.
Bachelor of Sciences degree, or higher, in a technical discipline (engineering, chemical or biological sciences) is required.
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.