Position Summary:
We are seeking a highly skilled CQV (Commissioning, Qualification, and Validation) Engineer for a contract position with a strong focus on DeltaV Automation. The successful candidate will be responsible for the qualification and validation of automated systems in a regulated biopharmaceutical manufacturing environment. This role involves executing CQV protocols, ensuring compliance with industry standards, and collaborating with cross-functional teams to optimize automation processes.
Key Responsibilities:
• Develop, review, and execute CQV protocols (IQ, OQ, PQ) for DeltaV automation systems.
• Ensure compliance with cGMP, GAMP5, 21 CFR Part 11, FDA, and other regulatory requirements.
• Conduct risk assessments, gap analyses, and validation impact assessments for automation systems.
• Collaborate with cross-functional teams including Quality, Engineering, and Manufacturing to ensure successful commissioning and qualification.
• Support troubleshooting, change management, and deviation resolution related to DeltaV automation.
• Maintain thorough documentation of validation activities and provide support for audits and regulatory inspections.
• Participate in system lifecycle management, continuous improvement initiatives, and validation strategy enhancements.
Required Qualifications:
• Bachelor's degree in Engineering, Life Sciences, Computer Science, or related field.
• 5+ years of CQV experience, with a strong background in DeltaV automation within pharmaceutical, biotech, or regulated industries.
• Expertise in cGMP, GAMP5, 21 CFR Part 11, and validation best practices.
• Hands-on experience with DeltaV configuration, troubleshooting, and validation.
• Strong analytical, problem-solving, and documentation skills.
• Ability to work independently and within a fast-paced, project-driven environment.
Preferred Qualifications:
• Experience in biopharmaceutical or aseptic manufacturing.
• Knowledge of MES integration, data integrity, and computerized system validation (CSV).
• DeltaV certification or formal training.