Packaging and Equipment Validation Engineer

Catalyx is seeking a Packaging and Equipment Validation Engineer to join our team and work on our customer site in Co. Waterford.

Who We Are:

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit

www.catalyx.ai.

Responsibilities:

• Validation Planning and Execution:

• Develop and execute validation plans for packaging processes and facilities.

• Ensure compliance with industry standards and regulatory requirements.

• Own and support validation activities in a medical device regulated environment.

• Resolve any issues encountered during validation.

• Maintain consistency in validation approaches across systems and projects.

• Packaging Design and Qualification:

• Lead packaging design, development, and qualification for sustaining engineering and new product development groups.

• Provide project support for packaging workstreams during new product launches, clinical trials, and limited market releases.

• Collaborate with cross-functional teams to ensure successful packaging development for injection and infusion devices.

• Apply knowledge of product design best practices, medical device development processes, and packaging technologies.

• Performance Testing and Quality Control:

• Measure production processes and parameters against established standards.

• Develop test procedures that produce analyzable validation data.

• Calibrate equipment to function within acceptable parameters.

• Interpret customer requirements related to packaging and equipment validation.

Qualifications:

• Bachelor’s degree in engineering, preferably in mechanical, industrial, or related fields.

• Proven experience in packaging validation, equipment qualification, or related roles within the medical device industry.

• Familiarity with regulatory guidelines (FDA, ISO, etc.) and quality management systems.

• Strong analytical skills and attention to detail.

• Excellent communication and collaboration abilities.

• Ability to work effectively in a cross-functional team environment.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.