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Automation CSV
4 weeks ago
Location: Ireland/ Remote
Job Summary:
VEQTOR is currently looking for an Automation CSV & CQV Engineer who has demonstrable expertise in the pharmaceutical or life sciences industry and wants to get involved in ensuring the compliance and validation of critical systems. We are seeking a professional with a background in working on validated systems and programs within regulated environments. In this position, the Automation CSV & CQV Engineer will play a crucial role in ensuring systems related to automation are compliant with regulatory requirements. This position involves daily activities focused on the validation of automation systems, documentation management, and adherence to quality standards. This position will be responsible for managing and executing Computer System Validation (CSV) and Commissioning, Qualification, and Validation (CQV) activities for automated systems. The Engineer will work closely with our clients to ensure that systems are properly validated and compliant with industry regulations. The right candidate should have familiarity with industry-specific regulations and guidelines related to CSV and CQV, such as FDA 21 CFR Part 11, GAMP, and GxP. The right candidate must have prior experience in conducting validation activities, producing validation documentation, and ensuring the compliance of automated systems in regulated environments.
Key Responsibilities:
- Develop and execute CSV strategies for automated systems, including equipment, software, and processes.
- Ensure that all automated systems are compliant with industry-specific regulations and guidelines, such as FDA 21 CFR Part 11 and GAMP.
- Plan, execute, and oversee CQV activities to ensure that automated systems meet predefined requirements and operate within validated parameters.
- Create and maintain validation documentation, including protocols, test scripts, and validation reports.
- Ensure that all automation systems comply with industry standards, GxP guidelines, and regulatory mandates.
- Maintain accurate and organized documentation for all validation activities, including equipment and software specifications, validation protocols, and records.
- Collaborate with our clients to ensure the proper documentation of automated system configurations.
- Identify and address potential risks and deviations during the validation process.
- Develop risk mitigation strategies and contingency plans to ensure the successful validation of systems.
- Conduct testing and qualification of automation systems to confirm functionality, performance, and compliance.
- Troubleshoot and resolve any issues or discrepancies identified during the testing process.
- Implement change control procedures to manage and document any changes or updates to automated systems post-validation.
- Ensure that change management activities adhere to regulatory requirements.
- Promote a culture of quality throughout the organization, ensuring that all processes and systems meet or exceed quality standards.
- Participate in internal and external audits to verify compliance with quality and regulatory requirements.
Required Skills & Experience:
- Educational level, if needed
- Certifications needed
- Years of experience needed
- Ability to sit/stand (percent of the time)
Preferred Skills & Experience:
- Plan, communication, and lead scientifically sound C&Q strategies for small to large scale projects.
- Familiarity with ASTM E2500 risk-based C&Q strategies, procedures, policies, and its practical application based on process knowledge and product requirements.
- Liaising with contractors, suppliers, and internal company stakeholders.
- Able to perform commissioning and qualification testing of DeltaV system and on manufacturing process equipment with automated process controls.
- Knowledge of minimal protocol requirements and ability to author various life cycle documents associated with automation C&Q and Validation.
- Ability to troubleshoot problems as they arise on a project – finding efficient and effective solutions.
- Knowledge of Validation policies and documentation for various systems and processes.
- B.S. in Science or Engineering discipline.
- Minimum of 2+ years of experience in validating DeltaV systems required.
