Summary: The Senior Cleaning Validation Engineer role is a contract position within a global pharmaceutical manufacturing organization in North Carolina. The engineer will be responsible for developing and executing cleaning validation strategies for a new manufacturing facility, collaborating with various teams to ensure compliance with regulations and successful qualification. This position offers an exciting opportunity to contribute to the organization's growth and operational readiness.

Key Responsibilities:

• Participate in CV conversations for CQV, involving operations, QA, QC, process support, and supply chain.
• Liaise with the operational readiness team and third-party contractors for cycle development and hold times.
• Document a strategy for executing CV at the site.
• Write and review cleaning and sanitization procedures and maintain the Cleaning Validation Master Plan.
• Collaborate with the CV team at the sister site in Denmark to clone SOPs and develop localization plans.
• Define roles and responsibilities during CV and gain alignment from supporting teams.
• Develop a communication strategy to inform the site about CV and work with the head of CQV for launch.
• Work with project managers to develop tracking tools for CV activities.
• Ensure alignment with regulations to support successful qualification and regulatory inspections.
• Act as SME for presenting cleaning validation to Regulatory (FDA) and auditors.

Key Skills:

• Experience in cleaning validation within the pharmaceutical industry.
• Strong understanding of regulatory requirements (FDA) related to cleaning validation.
• Excellent communication and collaboration skills.
• Ability to document and develop cleaning validation strategies and procedures.
• Experience working with cross-functional teams and third-party contractors.
• Project management skills for tracking and visibility of CV activities.
• Familiarity with SOPs and methods related to cleaning validation.

Salary (Rate): undetermined

City: undetermined

Country: United States

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: Senior

Industry: Other