CQV Engineer

CQV Engineer*This role is not open to C2C*Summary:Seeking a CQV Engineer to support commissioning, qualification, and validation activities for facilities, equipment, and utility systems in a regulated environment. This role involves protocol development, execution, and continuous improvement initiatives to ensure compliance with industry standards.Responsibilities:Develop and execute CQV documentation for facility, equipment, and utility systems, ensuring alignment with regulatory requirements.Prepare and review validation lifecycle documents, including user requirements, functional/design specifications, and qualification protocols.Translate system requirements into actionable validation protocols and oversee their implementation.Commission and qualify infrastructure, utility, and HVAC systems, conducting on-site field verification as needed.Perform performance testing, troubleshoot system issues, and ensure timely resolution during validation activities.Lead and participate in GxP and risk assessments, contributing to compliance and quality initiatives.Draft and review standard operating procedures, periodic reviews, and validation reports to support ongoing compliance.Mentor validation teams, provide guidance during protocol execution, and support continuous improvement and smarter compliance strategies.Qualifications:Bachelor's degree in Chemical Engineering, Biomedical Engineering, or a related field.5+ years of experience in CQV, equipment validation, process validation, or remediation work, preferably in cGMP environments.Experience in life sciences or GxP-regulated settings.Strong technical writing and documentation skills.Solid understanding of cGMP regulations and validation methodologies.Excellent problem-solving and analytical abilities.Adaptable, customer-focused, and a positive, proactive attitude.
*This role does offer relocation or sponsorship*