Job Overview:
We are seeking a highly experienced Clean Utilities Validation Engineer (CQV) to join our team in North Carolina for a large-scale biotech and greenfield project. As a Clean Utilities Validation Engineer, you will play a key role in ensuring the successful commissioning and validation of critical systems, such as water generation systems, clean steam generation systems, distribution systems, storage tanks, and process gas/air systems. The ideal candidate will have hands-on experience with the full Clean Utilities Validation lifecycle, including protocol drafting, execution, and summary report writing.

Responsibilities:

• Drafting commissioning and validation protocols for clean utilities systems (e.g., water generation, clean steam generation, process gas systems, etc.).
• Managing and executing deviations during the commissioning process.
• Drafting and executing protocols, including commissioning and validation plans.
• Writing and reviewing summary reports for validation activities.
• Reviewing specifications, vendor documents, and conducting field verification for clean utilities systems.
• Managing the full CQV lifecycle, including document review, commissioning execution, and writing summary reports.
• Ensuring compliance with industry standards, regulatory requirements, and company specifications.
• Collaborating with cross-functional teams to support commissioning and validation efforts.

Skills & Experience Required:

• Minimum of 5 years of hands-on experience as a Clean Utilities Validation Engineer, preferably in biotech or greenfield projects.
• Strong background in CQV (Commissioning, Qualification, and Validation) processes, particularly for water generation systems, clean steam generation systems, and process gas systems.
• Proficiency in writing and executing OQ/PQ (Operational Qualification/Performance Qualification) protocols.
• Expertise in OV (Operational Validation) and commissioning execution.
• Experience drafting commissioning protocols, managing deviations, and writing validation summaries.
• Familiarity with specification review and vendor document review.
• Ability to work independently and manage the validation process from start to finish.
• Strong attention to detail and a methodical approach to validation tasks.

Required Documents:

• Driver's License (Copy)
• Visa Copy (if applicable)
• At least two recent project references (mandatory).