CQV Engineer-Microbulk

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.