What are the responsibilities and job description for the CQV Engineer - Midwest position at Precision Technology?
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.
Contract Details:
- Duration: TBD (Based on project requirements)
- Location: On-site/Hybrid (Dependent on project needs)
- Compensation: Competitive, based on experience
This contract role offers an exciting opportunity to work with cutting-edge automation technologies in a regulated environment, contributing to the efficiency and compliance of pharmaceutical manufacturing operations.
