• Lead and oversee equipment, process, cleaning, and computerized systems validation within a biologics drug substance manufacturing environment
• Own and maintain the Master Validation Plan (MVP) and validation governance framework
• Develop and execute risk-based validation strategies aligned with cGMP, 21 CFR Part 11, and global regulatory expectations
• Review and approve validation protocols, reports, change controls, deviations, and CAPAs
• Partner closely with Manufacturing, Engineering, Quality, IT, and Regulatory teams to ensure seamless integration of validation activities
• Serve as a subject matter expert during audits, inspections, and regulatory interactions
• Lead continuous improvement initiatives to modernize validation processes and documentation
• Support technology transfer, scale-up, and new product introductions
• Mentor and develop validation team members while managing resources and budgets

• Validation programs are inspection-ready, compliant, and efficient
• Cross-functional teams view you as a trusted technical and quality leader
• Validation strategies evolve with regulatory expectations and industry best practices
• Issues are proactively identified, thoroughly investigated, and effectively resolved

• Bachelor’s degree in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or a related scientific field
• 5+ years of validation experience in a regulated pharmaceutical or biologics environment
• At least 2 years of people leadership or management experience
• Deep expertise across multiple validation disciplines
• Strong knowledge of cGMP and regulatory compliance requirements

• Master’s degree or higher
• 10+ years of validation experience in biologics or complex manufacturing environments

• Meaningful work supporting life-saving biologically based therapeutics used worldwide
• Competitive compensation package including base salary and recognition programs
• 401(k) with company match to support your long-term financial goals
• Generous paid time off (PTO) and paid holidays
• Career development and leadership growth opportunities within a global biopharmaceutical organization
• Collaborative, science-driven culture that values integrity, accountability, and continuous improvement
• High quality of life in Waunakee, WI! A growing community just outside Madison with excellent schools and outdoor recreation

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As one of the largest employer associations in the nation, MRA helps its member organizations thrive by offering the most comprehensive assortment of HR services, information, education, and resources to help build successful workplaces and a powerful workforce.

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