Systems Engineer II

Posted 16 Days Ago
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Hiring Remotely in Tallinn, Harju Maakond, EST
Remote
Entry level
Biotech
The Role
Leads engineering execution and technical coordination for custom Engineer-to-Order system projects. Translates customer requirements into compliant engineering deliverables, manages documentation and design controls, supports verification and acceptance testing, applies risk management principles, and coordinates multidisciplinary teams across the product lifecycle. The role also contributes to continuous improvement and standard product evolution within a GMP-regulated bioprocess equipment environment.
Summary Generated by Built In
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.
  • Evaluate customization requests for technical feasibility, compliance, cost, schedule, risks, and impact on standard products.
  • Translate customer needs into clear engineering deliverables and coordinate activities across mechanical, electrical, automation, and process engineering.
  • Support technical customer discussions, design reviews, risk assessments, and change requests.
  • Lead development of custom / Engineer-to-Order (ETO) 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

Skills Required

  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related technical discipline
  • Experience coordinating multidisciplinary engineering projects in 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
  • Proficiency with engineering documentation and product data management tools, including CAD and PDM/PLM platforms
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The Company
HQ: Waltham, MA
1,220 Employees

What We Do

FRAUD ALERT: Please take note that it has come to our attention that individuals purporting to work for Repligen are reaching out to prospective job applicants using fraudulent email addresses. All legitimate communications from Repligen will be sent from an individual with an email address ending in @repligen.com. If you have any concerns that a communication may be fraudulent and you would like to confirm whether it is, you may email [email protected] and someone will respond. Repligen is a bioprocessing-focused life sciences company bringing over 40 years of expertise and innovation to our customers. We are inspiring advances in bioprocessing through the development and commercialization of high-value products and flexible solutions that address critical steps in the production of biologic drugs, principally monoclonal antibodies. Repligen headquarters is in Waltham, Massachusetts and our manufacturing facilities are located around the world. We market our products globally through a direct commercial organization in the U.S., Europe and Asia, as well as through strategic partners in select markets.

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