Job Title: CQV Project Manager – Cleaning Validation

Location: Rhode Island (On-site)

Industry: Biopharmaceutical Manufacturing

Contract Type: Full-time / Contract

About the Role

EFOR is seeking an experienced CQV Project Manager to lead a Cleaning Validation initiative for a major biopharmaceutical manufacturing facility. This position requires end-to-end project oversight, team leadership, and cross-functional coordination to ensure timely and compliant execution of cleaning validation protocols across manufacturing systems and equipment.

You will lead a team of 5–6 CQV engineers and be responsible for aligning execution with the validation strategy, regulatory expectations, and internal quality systems.

Key Responsibilities

• Manage the full lifecycle of cleaning validation activities including:
• Risk assessments
• Cleaning feasibility studies
• Cleaning hold time studies
• Cleaning verification and validation protocol execution
• Lead a team of 5–6 engineers, assigning tasks, tracking deliverables, and ensuring adherence to project timelines
• Oversee the development and approval of validation documentation (URS, RA, protocols, reports)
• Track project KPIs, timelines, and resource needs using project management tools
• Represent CQV team in cross-functional meetings with QA, MS&T, Operations, and Engineering
• Coordinate deviations, change controls, and CAPAs related to cleaning validation scope
• Ensure compliance with GMP, FDA, EMA, and internal quality standards
• Facilitate the review and compilation of Turnover Packages (TOPs) and validation reports
• Report project status to client stakeholders and EFOR leadership

Required Qualifications

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field
• 10+ years of experience in validation/CQV in the biotech or pharmaceutical industry
• Proven experience managing cleaning validation programs
• Demonstrated success in leading CQV teams and driving project milestones
• Strong understanding of FDA/EU regulations, cleaning validation guidance (e.g., PDA TR49, ISPE), and ASTM E2500
• Solid communication, leadership, and stakeholder management skills

Preferred Qualifications

• Experience working with large-scale biomanufacturing environments
• Familiarity with automated cleaning systems (CIP/SIP) and multiproduct risk strategies
• Knowledge of digital validation tools such as Kneat or Veeva
• PMP certification or formal project management training
• Experience managing resource allocation and validation deliverables in fast-paced settings

Why EFOR?

EFOR is a global consulting leader in Life Sciences, with over 3,000 professionals delivering cutting-edge engineering and compliance services across biopharma and medical devices. We provide our consultants with challenging assignments, opportunities for growth, and a collaborative environment where your expertise shapes real-world innovation.

Ready to lead a critical validation effort in a dynamic environment? Join EFOR and make an impact.