CQV Engineer

Work Location: Frederick County, Maryland

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.

Published Category: Quality & Validation