CQV Engineer

Responsibilities:

• The role involves drafting and implementing Quality System documentation to promote effective validation practices within the organization.
• This includes authoring User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols, ensuring their execution aligns with Good Distribution Practice (GDP) guidelines and internal quality standards.
• Additionally, the position requires the design of validation strategies, supported by suitable statistical analyses, coordination of all validation activities, and the preparation of validation reports based on gathered results.
• Conducting Data Integrity Assessments and evaluating systems in accordance with 21 CFR Part 11 is also essential.
• The professional will offer insights regarding user and functional requirements for both current and future processing equipment, drafting necessary documentation while collaborating with manufacturers to ensure compliance with these requirements.
• Support for non-engineering personnel, particularly in Research and Development and Manufacturing, is crucial to facilitate successful technology transfer and ongoing improvements.
• Timely execution of assigned responsibilities is expected, with proactive communication regarding any delays or issues to the validation manager and other relevant stakeholders.
• The review of DeltaV software and specifications to formulate testing protocols is part of the duties, along with adherence to all regulatory, corporate, and Quality System policies.