DeltaV CQV Engineer
Date Posted: May 24, 2024
Job Description
We are currently seeking a highly skilled DeltaV CQV (Commissioning, Qualification, and Validation) Engineer to join our team for a Contract Development and Manufacturing Organization (CDMO) project based in Switzerland. The ideal candidate will have extensive experience with DeltaV systems and a strong background in CQV activities within the pharmaceutical or biotechnology industry. This role involves ensuring that all automation systems meet the required standards for performance, quality, and regulatory compliance.
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.
- Strong communication skills, with the ability to effectively interact with stakeholders at all levels of the organization.
- Proficiency in validation-related software and tools.
- Proven track record of successful project delivery and adherence to project timelines and budgets.
If you are keen to grow your career with this job, apply with us and send us your resume now. All shortlisted candidates will be contacted shortly.
Reference no.: 122-4948-2918-NW
Registration no.: 968446516E
