BioMarin is a leading global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California‑based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category‑defining medicines that have a profound impact on patients.QA Validation Associate12 month ContractSUMMARY DESCRIPTIONBioMarin 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.RESPONSIBILITIESProvide quality oversight for validation activities related to BioMarin’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) for the implementation of facilities, utilities and equipment changes while exercising judgment within broadly defined procedures and practices to establish approval criteria, and identify and implement solutions.Support 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 utilized at BioMarin.Lead and represent QA Validation in multi‑departmental meetings & project teams.Identify and implement improvements to the QA Validation systems.Participate 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, categorise, prioritise, mitigate and establish contingency plans associated with qualification / validation and system risks.EDUCATIONBachelor 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.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.CONTACTSThis 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 RESPONSIBILITYThere are currently no direct reports to this position.NOTEThis 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 EMPLOYERAn 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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