Cleaning Validation Engineer – Pharmaceuticals – North Carolina – Initial 3–6 Month Contract

We are partnering with a leading global pharmaceutical manufacturing organization seeking a skilled Cleaning Validation Engineer to join their expanding team. This role offers a unique opportunity to contribute to the establishment of a state-of-the-art manufacturing facility on the East Coast of the United States. With substantial investment and growth in their capital projects, this position is critical to the success of their operational readiness.

Key Responsibilities:

  • Participate in Cleaning Validation (CV) discussions for Commissioning, Qualification, and Validation (CQV), engaging cross-functional teams such as operations, QA, QC, process support, and supply chain.
  • Collaborate with operational readiness teams and third-party contractors to establish interactions for cycle development and hold times.
  • Develop and document the Cleaning Validation strategy for the site.
  • Draft and review cleaning and sanitization procedures while maintaining the Cleaning Validation Master Plan.
  • Partner with sister sites (e.g., Denmark) to leverage existing SOPs and methods, adapting them for localization at the Holly Springs facility.
  • Define roles and responsibilities for CV activities and secure alignment with supporting teams.
  • Assist the CV lead in creating a communication strategy to ensure site-wide awareness of CV initiatives, working closely with the CQV leadership team.
  • Collaborate with project managers to develop tools for tracking and monitoring CV activities.
  • Ensure compliance with all relevant regulations to support qualification and future regulatory inspections.
  • Act as Subject Matter Expert (SME) for cleaning validation during presentations to regulatory bodies (e.g., FDA), internal stakeholders, and external auditors.
  • Identify necessary SOPs and establish timelines for delivery, coordinating with responsible functions.
  • Partner with QC teams to define appropriate CV methods and sampling strategies.
  • Work with Supply Chain teams to develop material resourcing and storage strategies supporting CV activities.
  • Collaborate with QC and Operations to ensure personnel training is completed prior to CV execution.
  • Coordinate with CQV leads, CV leads, REs, and QA to implement the CV strategy across designated areas.
  • Develop a documentation plan and work with Kneat leads to prepare templates for execution.
  • Localize CV-related SOPs and documents for the FDBN site.
  • Investigate and resolve deviations or discrepancies during CV activities.

Required Experience:

  • 5–7 years of experience as a Cleaning Validation Engineer, with expertise in execution, Clean-In-Place (CIP) systems, and parts washers.
  • Proven ability to troubleshoot and resolve common CV issues.
  • Strong knowledge of regulatory compliance and readiness for inspections.
  • Experience collaborating with cross-functional teams and leading CV-related projects.

This is an excellent opportunity to bring your expertise to a high-profile project within a dynamic and innovative organization.