CQV Engineer

About the Role

CQV Engineers are responsible for the commissioning, qualification, and validation for facilities, utilities, and equipment in the pharmaceutical and biotech industries. Our engineers play a critical role in driving project success, while supporting validation planning, development, documentation, and execution, and ensuring regulatory standards and quality requirements are met.

Responsibilities

• Develop and execute commissioning, qualification, and validation protocols for required equipment and systems.
• Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures.
• Identify and assess risks associated with CQV activities and develop effective mitigation strategies.
• Troubleshoot and resolve issues related to equipment and process performance.
• Collaborative with cross-functional teams to ensure alignment on CQV activities and project timelines.
• Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).
• Additional responsibilities as required to drive successful validation project deliverables.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• 5 years minimum of equipment commissioning, qualification, and validation engineering experience in the pharmaceutical and/or biotech industries.
• Strong knowledge of regulatory requirements and industry standards.
• Experience with validation lifecycle management and risk-based approaches.
• Excellent analytical and technical problem solving skills.
• Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.).
• Effective communication and interpersonal skills.
• Proactive with strong organization, time management, and project management abilities.
• Excellent attention to detail with commitment to quality and compliance.
• Willing and able to travel as needed for project assignments and client engagements. Ability to adapt to different locations, cultures, and work environments.
• Must be authorized to work in the US.