CQV Engineer-Microbulk

We are seeking an experienced CQV Engineer to support the commissioning and qualification of a Bulk CO2 Gas System. This role involves developing and executing comprehensive commissioning and qualification (C&Q) documentation to ensure the system meets performance, safety, and compliance requirements. The ideal candidate will have expertise in gas system qualification, gas sampling coordination, and CQV processes within regulated industries.

Key Responsibilities:

• Develop, review, and execute commissioning and qualification protocols for the Bulk CO2 Gas System.
• Conduct functional and performance testing to validate system compliance with operational and regulatory standards.
• Coordinate gas sampling activities, including scheduling, execution, and documentation.
• Ensure all activities align with Good Documentation Practices (GDP) and industry regulations.
• Identify and address discrepancies or issues discovered during commissioning and qualification.
• Collaborate with cross-functional teams, including engineering, quality, and operations, to ensure project milestones are achieved.
• Prepare detailed reports and documentation for project handover and regulatory audits.
• Ensure compliance with applicable regulatory requirements such as GMP, FDA, and ISO standards.

Requirements

Required Qualifications:

• Proven experience in commissioning and qualification of gas systems, including bulk CO2 systems.
• Strong background in coordinating gas sampling activities and related data analysis.
• 2- 7 years CQV experience within regulated environments such as life sciences, pharmaceuticals, or biotechnology.
• Exceptional attention to detail, problem-solving skills, and a commitment to quality.
• Excellent written and verbal communication skills for documentation and collaboration.

Preferred Qualifications:

• Bachelor’s degree in engineering, life sciences, or a related technical field.
• Familiarity with bulk gas systems and distribution networks in GMP-compliant facilities.
• Knowledge of regulatory requirements for gas systems, including safety and operational standards.
• Certification or training in CQV, gas systems, or related technical disciplines.