Job Overview
The role of Automation CQV/CSV Engineer involves developing and executing commissioning, qualification, and validation protocols for automation and control systems. This includes ensuring compliance with GMP, GAMP 5, and 21 CFR Part 11 during all phases of system implementation and operation.
As an Automation CQV/CSV Engineer, you will be responsible for authorizing and maintaining validation documentation, including protocols, reports, and traceability matrices for computerized systems. You will also conduct risk assessments and impact analyses to determine validation scope and ensure data integrity.
Additionally, you will support deviation management, including investigation, resolution, and documentation of issues encountered during validation. Collaboration with cross-functional teams (QA, IT, Engineering, Manufacturing) is essential to ensure seamless integration and validation of automation systems.
Responsibilities
* Develop and execute commissioning, qualification, and validation protocols (DQ, IQ, OQ)
* Ensure compliance with GMP, GAMP 5, and 21 CFR Part 11
* Author and maintain validation documentation
* Conduct risk assessments and impact analyses
* Support deviation management
* Collaborate with cross-functional teams
Requirements
* University degree or equivalent qualification in Engineering or similar scientific field
* Relevant experience in installation management or equipment qualification and automation
* Training and experience of GMP and HSE practices
* Relevant understanding and knowledge of legislation applicable to engineering projects and quality requirements
* Competent English language skills
What We Offer
We value diversity and inclusion in the workplace and strive to create a work environment where everyone feels supported and respected. If you are passionate about innovation and excellence, we encourage you to apply for this role.