Automation Validation Engineer- Midwest

Precision Life Sciences - Windham, NH, United States

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.

 



Posted On: Thursday, March 6, 2025



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