Overview
Skills
Job Details
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 |