Automation Engineer for System Validation and Compliance

1 day ago

Newtown, Ireland Xyntek Inc. Full time

Catalyx is a leading company in operational process science, with a global presence across North America and Europe. We specialize in automating and servicing R&D, production, packaging, and delivery processes, using a sophisticated blend of products, technologies, and lifecycle services.

The company was formed in 2022 through the merger of CXV Global and Panacea Technologies, bringing together over three decades of expertise in helping organizations optimize their operational efficiency, performance, and safety in highly regulated industries.

We are seeking an Automation Engineer to join our fast-paced engineering team, responsible for validation and qualification activities as part of our overall System Development Lifecycle (SDLC) approach.

Responsibilities
  • Developing and managing GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols, and Standard Operating Procedures.
  • Writing and executing IQ and OQ protocols, communicating with vendors to ensure project requirements are met.
  • Managing and coordinating all aspects of validation activities, including project planning, developing validation strategies, document development and reviews, and overseeing system change requests and associated documentation.
  • Maintaining SOPs pertaining to the Quality Management System, utilizing a risk-based approach to determine validation requirements.
  • Configuration specifications generation detailing the specific configuration of systems/interfaces.
Requirements
  • Bachelor's degree in Chemical Engineering or related field; Mechanical Engineering, Electrical Engineering, Computer Engineering, or Industrial Engineering also considered.
  • Excellent technical writing and communication skills.
  • Experience in Life Sciences, Pharmaceutical, Medical Devices industries preferred; experience in systems validation/QA within FDA regulated environments also beneficial.
  • Industrial process validation essential; ideally, experience with equipment validation, instrument validation, and packaging validation.
  • Validating and qualifying various software and IT systems utilized in industrial automation environment, with thorough knowledge of GAMP5 concepts.

At Catalyx, we prioritize our people, offering a Total Rewards package that includes competitive salaries, annual performance-based raises and bonuses, paid Time Off Packages, medical benefits, and opportunities for career and professional growth.

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