This position is responsible for supporting 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. RESPONSIBILITIES Key Subject Matter Expert (SME) and Quality Oversight representative in specific validation discipline(s). Maintains current knowledge of industry standards and regulatory requirements for validation techniques / approaches utilized at BioMarin. Supports the QA Validation group in maintaining regulatory compliance, in line with industry best-practices in specific validation discipline(s). Supports complex investigations, regulatory submissions, specific regulatory queries and agency inspections in SME areas of expertise. Supports strategy development and ensures regulatory compliance for validation projects. Strategically supports complex validation projects across a variety of disciplines. Provision of mentorship and SME support to more junior members of the QA Validation team and cross functional groups as applicable. Lead and represent QA Validation in multi-departmental meetings & project teams. Identifies and leads implementation of improvements to validation systems.? Quality Oversight for Validation execution activities related to the?various validation disciplines. This includes supporting and reviewing / approving validation lifecycle documentation e.g. URS, Risk Assessments, Commissioning Documents, Qualification Protocols, Revalidation / Periodic Review Reports. Supports development of validation plans for specific system implementation projects. Establishes site validation policies, through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures.? Provide Quality Oversight for any assigned?change requests, deviations, quality events and associated CAPAs.? Other duties as assigned. EDUCATION Bachelor of Sciences degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required. EXPERIENCE +5 yearsexperience in a cGMP regulated manufacturing environment, with demonstrated knowledge of facility, equipment, utility, process, lab systems and CSV 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. CONTACTS This 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 RESPONSIBILITY There are currently no direct reports to this position. ~~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. Skills: +5 Years experience in GMP environment CSV Validation SME
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