Commissioning & Validation Engineer (Clean/Utilities)

Position: Commissioning & Validation Engineer (Clean/Black/Dirty Utilities)

Project Type: Greenfield Biopharma Manufacturing Facility

Employment Type: Contract

Work Schedule: Requires onsite presence daily (no remote option)

Position Overview

We are seeking qualified Commissioning & Validation Engineers with strong experience in utility systems to support a large-scale greenfield biopharmaceutical project. This role involves hands-on execution and documentation of commissioning and validation activities for clean utilities, black utilities, and process utilities. The ideal candidate will have demonstrated expertise in reviewing P&IDs, developing technical documentation, managing validation deliverables, and maintaining compliance in a highly regulated environment.

Key Responsibilities

• Lead and execute Commissioning and Validation (Cx & V) activities for clean, black, and process utility systems.
• Prepare, review, and execute User Requirement Specifications (URS), Design Specifications (DS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and associated reports.
• Review and interpret Piping and Instrumentation Diagrams (P&IDs) and system design drawings to ensure design accuracy and compliance prior to commissioning.
• Coordinate with Engineering, Automation, QA, and Construction teams to ensure system readiness and adherence to design and GMP standards.
• Maintain all validation and commissioning documentation in eQMS systems (e.g., Veeva), SharePoint, and related project tracking tools.
• Support deviation management, change controls, and audit preparation related to commissioning and validation activities.
• Apply basic project management principles to track deliverables, maintain schedules, and report progress effectively.
• Ensure compliance with all Health, Safety, and Environmental (HSE) requirements, promoting safe work practices in active construction and startup areas.
• Collaborate cross-functionally to ensure system turnover and qualification milestones are met according to project timelines.

Qualifications

• Bachelor’s Degree in Engineering, Life Sciences, or related technical discipline.
• Minimum 5 years of experience in commissioning and validation within the pharmaceutical, biotechnology, or regulated manufacturing industries.
• In-depth knowledge of:
• Clean utilities: WFI, Clean Steam, Compressed Air, Process Gases
• Black utilities: Chilled Water, Boilers, HVAC, Plant Air, Cooling Water
• Proven experience in P&ID review and system design verification.
• Proficiency in drafting, reviewing, and executing validation documentation and summary reports.
• Hands-on experience with Veeva eQMS, SharePoint, and Microsoft Excel (data tracking, dashboards, pivot tables).
• Strong working knowledge of cGMP, FDA, and ISPE commissioning and qualification guidelines.
• Demonstrated commitment to HSE standards and site safety protocols.
• Strong communication, analytical, and interpersonal skills; capable of working independently or within cross-functional teams.

Preferred Qualifications

• Experience using Kneat Gx for digital validation documentation and execution.
• Previous participation in greenfield or large-scale expansion projects.
• Familiarity with automation systems such as DeltaV, BMS, or SCADA.
• Certifications such as PMP, CQV, or Six Sigma are considered an asset.

Best Regards,

Satya Satish J | Technical Recruiter | IT Minds LLC |