Validation Team Leader

WHAT YOU WILL ACHIEVE:

In this role, you will lead the Middleton Site validation team, including colleagues and contractors, to deliver compliant, effective, and sustainable validation programs. You will enable successful execution of cleaning, equipment, and process validations, periodic validation reviews, and continuous improvement initiatives that support site operations and regulatory readiness. As the site validation subject matter expert, you will partner closely with Site Leadership, Quality, Engineering, Production, and network stakeholders to identify, prioritize, and implement improvements that strengthen validation capabilities and drive long‑term site performance.

ROLE SUMMARY:

In this role, you are responsible for leading and sustaining robust validation and cleaning programs at the Middleton site. You serve as the site validation subject matter expert, providing both technical and strategic oversight to ensure all validation activities are executed in full compliance with cGMP requirements, internal SOPs, and site Validation Master Plans. Leveraging your deep expertise in validation and strong understanding of related disciplines, you will maintain the facility’s Validation Master Plans, guide complex cross‑functional initiatives, and ensure validation strategies align with regulatory expectations and organizational objectives.

You operate with a high degree of autonomy, setting direction and priorities for a team of validation professionals while fostering accountability, engagement, and continuous improvement. As a visible leader, you will collaborate with senior internal and external stakeholders, represent the validation team in technical and regulatory discussions, and drive innovation in the Middleton site’s validation programs to support both current operations and future growth.

ROLE RESPONSIBILITIES:

• Lead site‑level validation and cleaning programs by applying technical expertise in validation disciplines, industry standards, and cGMP requirements to ensure compliant execution of defined processes.

• Develop, maintain, and implement the site Validation Master Plans in alignment with regulatory expectations, internal standards, and operational needs.

• Provide clear goals, priorities, and direction for validation colleagues and contractors, ensuring validation activities are executed in accordance with SOPs, Validation Master Plans, and quality system requirements.

• Serve as the Middleton Site validation subject matter expert, maintaining strong working knowledge of related disciplines and collaborating cross‑functionally to support integrated and compliant outcomes.

• Resolve complex validation and operational challenges by gathering and analyzing information from multiple sources, identifying root causes, and implementing practical, compliant solutions aligned with site and organizational objectives.

• Plan, manage, and coordinate multiple validation projects and ongoing work activities of moderate complexity, ensuring delivery against timelines, resource plans, and budget expectations.

• Sustain and continuously improve the Middleton Site validation programs by identifying opportunities to strengthen processes, documentation, and execution effectiveness.

• Lead, coach, and develop validation team members by fostering engagement, accountability, and effective collaboration while supporting appropriate independence in day‑to‑day assignments.

• Partner closely with Site Leadership, Quality, Engineering, Production, and network stakeholders to support validation planning, execution, and continuous improvement initiatives.

• Represent the site in internal and external technical discussions, including audits, briefings, and meetings related to validation and qualification requirements

BASIC QUALIFICATIONS:

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience;
  OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience

• Manufacturing experience in a pharmaceutical GMP environment

• Language Skills: Effective written and oral communication

• Computer Skills: Microsoft Applications

• Project execution: History of delivering on project deliverables and experience in leading significant investigations and/or site-wide initiatives or program changes.

• Mentoring: Demonstrated me