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Are you a meticulous Quality Engineer with a passion for software validation? We are seeking a Software Quality Engineer to join our team in Witney for a high-impact, 12-month contract. In this role, you will focus on Non-Product Software Validation, ensuring that the internally developed software used for our critical product testing and automation meets strict regulatory standards. You will be the bridging link between quality compliance and cutting-edge software updates, adapting our systems to handle next-generation products. Whether you are an ambitious professional looking to grow or an experienced validation specialist, the broad salary band allows us to tailor this role to your level of expertise.
Job Responsibility
Non-Product Software Validation: Taking ownership of the validation lifecycle for internally developed software used explicitly for product testing and manufacturing operations
Supporting Product Expansion: Managing software changes and updates required to seamlessly introduce and test new product types
Automation Engineering Collaboration: Working hand-in-hand with the automation and software teams to validate brand-new automated test systems for upcoming product launches
Lifecycle Documentation: Writing, reviewing, and executing validation protocols (IQ/OQ/PQ) to ensure software compliance
Requirements
Proven experience within the Medical Device or Pharmaceutical sectors is highly preferred
open to candidates from other highly regulated environments (e.g., Aerospace, Automotive) who understand rigorous compliance
strong understanding of software validation principles (GAMP 5, 21 CFR Part 11, or similar standards) and non-product software assurance
ability to work closely with cross-functional teams, particularly software developers and automation engineers