CQV Manager / Project Manager

EFOR; Providence (RI); On-site; USD 104,000 - 156,000; Full time

Job summary

A leading company in biopharmaceutical manufacturing is seeking a CQV Project Manager to oversee cleaning validation initiatives. The role involves managing a team, ensuring compliance with regulatory standards, and driving project milestones in a dynamic environment.

Benefits

Medical insurance

401(k)

Vision insurance

Disability insurance

Qualifications

• 10+ years of experience in validation/CQV in the biotech or pharmaceutical industry.
• Demonstrated success in leading CQV teams and driving project milestones.

Responsibilities

• Manage the full lifecycle of cleaning validation activities.
• Lead a team of 5–6 engineers, assigning tasks and tracking deliverables.
• Ensure compliance with GMP, FDA, EMA, and internal quality standards.

Skills

Leadership

Communication

Stakeholder Management

Education

Bachelor’s or Master’s degree in Engineering, Life Sciences

Tools

Digital Validation Tools

Job description

1 day ago Be among the first 25 applicants

Engineer | Senior Business Manager | @ EFOR

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:
• Cleaning feasibility 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
• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Consulting, Engineering, and Project Management

• Industries

  Business Consulting and Services, Pharmaceutical Manufacturing, and Biotechnology Research

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Inferred from the description for this job

Medical insurance

401(k)

Vision insurance

Disability insurance

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