Senior Process Technician

This position supports multi-product development, R&D project execution, and technology transfer activities. Based in Waterford, Ireland, it is focused on the development of Fluid Technologies supporting multiple Repligen business units. Working closely with R&D and Manufacturing teams, the role plays a key part in new product development, prototype manufacturing, first article builds, process development, product testing, and validation. The successful candidate will be responsible for the hands-on assembly, manufacture, inspection, testing, and documentation of prototypes and pre-production products, supporting projects from concept through to commercialization.

Collaborating with R&D, Manufacturing, Quality, Supply Chain, and Regulatory teams, the technician will help develop robust products and scalable manufacturing processes while ensuring testing and validation activities meet company quality standards. Strong mechanical aptitude, an understanding of a range of manufacturing and assembly techniques, and excellent problem-solving skills are essential for success in this role.
Prototype Manufacturing & First Article Builds:

- Manufacture, assemble, and inspect prototype and first article products in support of development projects.
- Build engineering samples, pilot units, and pre-production assemblies from engineering drawings and work instructions.
- Support development of manufacturing methods for new products.
- Identify assembly, manufacturability, and design issues during prototype builds.
- Provide feedback to engineering teams regarding product design, assembly efficiency, and process improvements.
- Maintain build records, assembly documentation, and traceability information.
- Support pilot production and new product introduction (NPI) activities.

Product Development Support:

- Assist R&D Engineers in the development of new products and technologies.
- Construct and modify prototype assemblies, fixtures, and test equipment.
- Participate in design reviews and development projects.
- Support engineering investigations and troubleshooting activities.
- Assist with design verification and product qualification activities.
- Contribute to continuous improvement initiatives related to products and processes.

Product Testing & Validation:

- Execute verification, validation, and qualification testing activities in accordance with approved protocols.
- Perform functional, mechanical, pressure, flow, leak, burst, environmental, and performance testing as required.
- Support IQ, OQ, PQ, design verification, process validation, and product validation activities.
- Record and analyse test data accurately and in compliance with Good Documentation Practices.
- Prepare test samples and equipment required for validation studies.
- Identify and report non-conformances, deviations, and unexpected test results.
- Assist in root cause investigations and corrective action activities
- Process Development · Support process characterization and optimization activities.
- Assist in developing robust manufacturing and assembly processes for new products.
- Conduct engineering trials and process studies.
- Support technology transfers from R&D to manufacturing operations.
- Evaluate process capability and identify opportunities for improvement.
- Assist in creation and refinement of manufacturing work instructions and procedures. Laboratory & Engineering Support
- Operate laboratory, workshop, and manufacturing equipment safely and effectively.
- Maintain test equipment, fixtures, tools, and laboratory resources.
- Perform dimensional inspections and product evaluations.
- Coordinate procurement and organization of prototype materials and components.
- Support inventory management of engineering materials and laboratory consumables.

Documentation & Compliance:

- Maintain accurate laboratory notebooks, test records, and build documentation.
- Complete test reports and summaries of results.
- Support creation and execution of engineering protocols and reports.
- Ensure compliance with quality systems, GDP, GMP, and site procedures where applicable.
- Support design history files (DHF), device master records (DMR), and technical documentation requirements.
- Maintain traceability of materials, components, assemblies, and test samples.

Cross-Functional Collaboration:

- Work closely with R&D, Manufacturing, Quality, Operations, and Supply Chain teams.
- Support manufacturing readiness and process transfer activities.
- Participate in project meetings and design reviews.
- Provide regular updates on build status, testing progress, and technical issues.
- Support customer demonstrations, audits, and engineering evaluations when required.