CQV Consultant

Key Responsibilities

• Develop and execute commissioning, qualification, and validation (CQV) protocols for DeltaV automation systems.
• Ensure that all DeltaV systems are validated according to industry standards and regulatory requirements, including GMP and FDA regulations.
• Collaborate with cross-functional teams to define automation and validation requirements and develop detailed validation plans.
• Conduct risk assessments and gap analyses to identify potential issues and develop mitigation strategies.
• Oversee the execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Configure and program DeltaV distributed control systems (DCS) to meet project objectives and performance criteria.
• Conduct testing, validation, and commissioning of DeltaV systems to ensure reliability, accuracy, and compliance with regulatory standards.
• Prepare and maintain comprehensive validation documentation, including protocols, reports, and standard operating procedures (SOPs).
• Provide technical support and troubleshooting expertise for DeltaV systems, ensuring timely resolution of issues.
• Stay informed about industry trends, regulatory changes, and best practices in DeltaV automation and CQV processes, and propose innovative solutions to enhance operational efficiency and compliance.

Required Qualifications and Skills

• Bachelor’s degree in Engineering, Automation, or a related field.
• Minimum of 5 years of experience in CQV engineering within the pharmaceutical or biotechnology industry, with a focus on DeltaV systems.
• Strong understanding of GMP regulations and their application to automation and validation processes.
• Proven experience in developing and executing CQV protocols, including IQ, OQ, and PQ.
• Proficiency in configuring and programming DeltaV DCS, including knowledge of batch processing and recipe management.
• Excellent problem-solving skills and the ability to work effectively in a fast-paced, team-oriented environment.
• Proficiency in validation-related software and tools.