Roles & Responsibilities:
• Independently draft and execute complex validation plans, protocols, and test strategies to ensure compliance and expedited release of critical site equipment.
• Balance competing priorities while ensuring global work is conducted per regulatory requirements and company procedures.
• Serve on internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality-related issues and support continuous improvement.
• Train personnel in quality and validation principles.
• Support Engineering and other departments in the selection, review, acquisition, and upgrade of systems and production equipment.
• Provide technical support in developing user and functional requirements specifications (URS, RA, FRS, DQ) for systems and equipment.
• Act as Lead Validation representative on assigned project teams; communicate new requirements and perform training with Validation team to assure timelines are met for successful project completion and product launches.
• Share quality philosophies throughout Operations and support Production and Engineering.
• Perform all company business in accordance with regulations (EEO, FDA, etc.) and company policies.
• Develop audit responses and complete CAPAs by target due dates; ensure Validation areas are "inspection ready” at all times.
• Execute actions required to support Change Control, Deviation, and CAPA on-time closure.
Education & Experience :
• Minimum 6 years GMP validation or similar experience in a GMP manufacturing/production environment.
• Minimum 10 years GMP validation experience in a GMP or regulated manufacturing environment in lieu of a degree.
• At least 3 years leading projects.
• Ability to plan, schedule, organize, prioritize, and coordinate project activities.
• Ability to function in a leadership role and within cross-functional teams.
• Ability to analyze validation and production data to assess compliance with GMP requirements and troubleshoot compliance problems.
• Excellent written and verbal communication skills.
• Strong comprehension/application of FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles.
• Strong theoretical and practical knowledge of regulated processes and one technical discipline (e.g., biology).
• Ability to make decisions regarding product acceptability based on documentation.
• Demonstrated ability to work with diverse groups and manage conflict.
• Proficiency in MS Word, Excel, Outlook, and PowerPoint.
• Bachelor's degree, preferably in a science or engineering-related field.