CQV Engineer- QC EM Sampling

Job Summary:

We are looking for an experienced CQV Engineer to support a project involving commissioning and qualification activities for a modified Gas Distribution System. The ideal candidate will have expertise in gas system qualification, sampling coordination, and end-to-end CQV processes. This role will focus on ensuring all modifications meet industry standards, regulatory requirements, and operational efficiency goals.

Key Responsibilities:

• Develop, review, and execute commissioning and qualification (C&Q) documentation for the modified Gas Distribution System.
• Perform functional testing and qualification activities to verify system performance and compliance with project specifications.
• Coordinate gas sampling activities, including scheduling, logistics, and reporting.
• Identify and resolve system discrepancies during commissioning and qualification activities.
• Collaborate with engineering, quality, and operations teams to ensure project objectives are met within established timelines.
• Document test results and prepare detailed reports to support project handover and regulatory audits.
• Ensure adherence to Good Documentation Practices (GDP), regulatory standards, and project-specific requirements.
• Support risk assessments and mitigation planning for gas distribution system modifications.

Requirements

Required Qualifications:

• Proven experience with gas system qualification and commissioning.
• Hands-on experience coordinating gas sampling activities, including working with third-party vendors or internal teams.
• 2- 7 years expeirence of CQV processes in regulated environments such as life sciences, pharmaceuticals, or manufacturing.
• Excellent documentation skills, with attention to detail and regulatory compliance.
• Strong problem-solving, organizational, and communication skills.

Preferred Qualifications:

• Bachelor's degree in engineering, life sciences, or a related field.
• Familiarity with gas distribution systems in GMP-regulated facilities.
• Experience with regulatory guidelines such as FDA, ISO, or GMP standards.