Systems Engineer II

The Systems Engineer is an individual contributor within the R&D organization responsible for leading the engineering execution and technical coordination of Engineer-to-Order (ETO) custom system projects. This role serves as the technical focal point for customer-specific solutions, ensuring that customer requirements are translated into robust engineering deliverables while maintaining compliance with quality, regulatory, and business requirements.
Operating in a global, fast-paced, and customer-focused environment, the Systems Engineer collaborates closely with Mechanical, Electrical, Process, and Automation Engineering teams, as well as Product Management, Quality, Operations, Service, Supply Chain, and Commercial functions to successfully deliver custom solutions from concept through customer acceptance.
This position reports to the Sr. Manager – Systems Engineering & Lifecycle Management.
Develop and maintain engineering documentation, specifications, risk assessments, and change-control records in accordance with design control requirements.
Support verification, testing, and customer acceptance activities to ensure solutions meet performance and quality requirements.
Apply systems engineering and risk management principles throughout the product lifecycle.
Partner with Product Management, Quality, Operations, Supply Chain, Service, and Commercial teams to ensure successful project delivery.
Facilitate communication and alignment across engineering disciplines and stakeholders.
Contribute to continuous improvement initiatives and the evolution of standard products through lessons learned from custom projects.
Qualifications
Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related technical discipline.
Experience coordinating multidisciplinary engineering projects and working within stage-gate product development and manufacturing environments.
Knowledge of design controls, risk management, FMEA, and engineering documentation practices.
Experience with single-use systems, bioprocess equipment, GMP-regulated environments, and automation integration is strongly preferred.
Proficiency with engineering documentation and product data management tools, including CAD and PDM/PLM platforms.
Repligen offers you a competitive remuneration package, including a yearly bonus, additional health insurance package, sport benefits and flexible working hours. But most importantly Repligen offers you a stimulating, fast--paced environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team and a modern office in Jüri, Estonia