Senior Process Technician

About the role

Repligen develops and manufactures biologic medicines. As a Senior Process Technician you will work at the interface of R&D, Manufacturing, Quality and Engineering, supporting new product development, prototype manufacturing, process development, testing and technology transfer. The role suits a technically skilled, mechanically minded person who enjoys solving complex challenges in a fast-paced environment.

Key responsibilities

• Build, assemble and inspect prototypes, pilot units and pre-production products from engineering drawings and work instructions, and manufacture and mold prototype silicone components.
• Work with R&D engineers to develop prototypes, fixtures and test equipment, and identify manufacturability and design improvements.
• Run product verification, validation and qualification tests (mechanical, pressure, flow, leak, performance) and document results, investigating issues and supporting root cause analysis.
• Assist in process characterization, engineering trials and the development of robust manufacturing processes.
• Support NPI and technology transfer, and improve work instructions, assembly methods and process documentation.
• Operate and maintain laboratory, workshop and manufacturing equipment safely, and conduct inspections and product evaluations.
• Maintain build records, test documentation and traceability, and support validation protocols, technical reports and compliance with quality systems, GDP, GMP and regulatory requirements.
• Collaborate with R&D, Manufacturing, Quality, Operations, Supply Chain and Regulatory teams, and support customer demonstrations, audits and engineering reviews.

Required profile

• Technical qualification (Level 6 or equivalent) in Mechanical Engineering, Manufacturing Engineering, Mechatronics, Process Engineering or a related discipline.
• 5+ years of experience in manufacturing, engineering, R&D or product development.
• Experience assembling mechanical, fluid handling or electromechanical systems.
• Ability to interpret engineering drawings, technical documentation and assembly instructions.
• Experience supporting testing, validation or qualification activities.

Required skills

• Excellent troubleshooting, analytical and problem-solving skills.
• Interpretation of engineering drawings and technical documentation.

What we offer

• A competitive remuneration package including a yearly bonus.
• Private medical insurance.
• Flexible working hours.
• An international team in Waterford, Ireland, in a fast-paced environment with steep learning curves.