Clean Utilities Validation Engineer

Clean Utilities Validation Engineer

Location: Onsite – GMP Pharmaceutical Manufacturing Facility

Industry: Pharmaceutical CDMO (Fill/Finish Operations)

Project Overview

Our client, a pharmaceutical Fill/Finish CDMO, is seeking a highly experienced Clean Utilities Validation Engineer to support qualification, remediation, and lifecycle management activities for critical utility systems within a GMP manufacturing environment.

This role will focus on establishing standardized validation lifecycle practices, developing corporate validation standards, and executing qualification activities for clean and process utility systems. Initial priorities include remediation and qualification efforts involving RODI, WFI, Nitrogen, and other GMP utility systems.

The ideal candidate is an independent validation professional capable of identifying compliance gaps, driving remediation plans, and executing validation strategies with minimal supervision.

Responsibilities

• Lead qualification and lifecycle validation activities for clean and process utility systems.
• Develop and implement validation strategies, protocols, and lifecycle documentation.
• Author and execute IQ, OQ, PQ, commissioning, and requalification protocols.
• Support remediation and compliance improvement initiatives for existing utility systems.
• Develop corporate validation standards and best practices for utility qualification.
• Perform gap assessments and recommend corrective actions to achieve GMP compliance.
• Collaborate with Engineering, Facilities, Quality Assurance, and Manufacturing teams.
• Review utility system designs, P&IDs, specifications, and turnover packages.
• Support deviation investigations, CAPAs, change controls, and periodic reviews.
• Ensure validation activities comply with FDA, EU GMP, ISPE, and industry standards.

Required Qualifications

• 5+ years of validation experience within GMP pharmaceutical or biotechnology manufacturing.
• Strong experience qualifying and validating:
• RODI Systems
• WFI Systems
• Clean Steam Systems
• Compressed Air Systems
• Nitrogen Systems
• Process Utility Systems
• Experience developing validation lifecycle programs and corporate standards.
• Demonstrated experience leading remediation and compliance improvement projects.
• Strong understanding of GMP regulations and validation requirements.
• Ability to work independently and drive projects to completion.

Preferred Qualifications

• Experience in sterile manufacturing or fill/finish facilities.
• Familiarity with ISPE Baseline Guides and ASTM validation methodologies.
• Experience supporting FDA or regulatory inspections.