Job Summary:
At VEQTOR, we are seeking an experienced Automation CSV & CQV Engineer to join our team in Ireland or remotely.
The ideal candidate will have a background in working on validated systems and programs within regulated environments, with expertise in the pharmaceutical or life sciences industry.
This role is crucial in ensuring that systems related to automation are compliant with regulatory requirements. The Automation CSV & CQV Engineer will be responsible for managing and executing Computer System Validation (CSV) and Commissioning, Qualification, and Validation (CQV) activities for automated systems.
The successful candidate will work closely with clients to ensure that systems are properly validated and compliant with industry regulations, such as FDA 21 CFR Part 11, GAMP, and GxP.
Key Responsibilities:
* Develop and execute CSV strategies for automated systems, including equipment, software, and processes.
* Ensure compliance of automated systems with industry-specific regulations and guidelines.
* Plan, execute, and oversee CQV activities to meet predefined requirements and operate within validated parameters.
* Create and maintain validation documentation, including protocols, test scripts, and validation reports.
* Maintain accurate and organized documentation for all validation activities.
* Collaborate with clients to document automated system configurations.
* Identify and address potential risks and deviations during the validation process.
* Develop risk mitigation strategies and contingency plans.
* Conduct testing and qualification of automation systems to confirm functionality, performance, and compliance.
* Troubleshoot and resolve issues identified during testing.
* Implement change control procedures to manage and document changes or updates to automated systems post-validation.
* Ensure change management activities adhere to regulatory requirements.
Requirements:
* Educational level: Bachelor's degree in a relevant field.
* Certifications: Relevant certifications in CSV and CQV.
* Experience: Minimum 2+ years of experience in validating DeltaV systems.
* Skillset: Strong understanding of industry-specific regulations and guidelines, excellent communication and planning skills.
PREFERRED SKILLS AND EXPERIENCE:
* Familiarity with ASTM E2500 risk-based C&Q strategies and its practical application.
* Liaising with contractors, suppliers, and internal stakeholders.
* Able to perform commissioning and qualification testing of DeltaV systems and 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 efficiently and effectively.
* Knowledge of Validation policies and documentation for various systems and processes.