Commissioning & Validation Engineer (Clean/Black/Dirty Utilities) at IT MINDS L.L.C. Lebanon, IN

Commissioning & Validation Engineer (Clean/Black/Dirty Utilities) Job Description: 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. #J-18808-Ljbffr Itlearn360