Overview

Repligen’s Process Analytics team is actively seeking a highly motivated and skilled Spectroscopy Systems Engineer with a passion for driving innovation in the bioprocessing sector. The successful candidate will play a crucial role in the design, development, and analysis of advanced Mid-IR analytical instruments integral to the advancement of process analytical technologies (PAT).

This individual will play the technical lead role in product development and will craft product system requirements and steer the verification and validation processes. The role necessitates a profound grasp of robust opto-mechanical design practices, precision mechanisms, lasers, thermal control, and the application and development of chemometric models. The Mid-IR spectroscopic instruments developed will be vital for monitoring, controlling, and regulating Pharma or Biotech processes in laboratory and production environments.

Collaborating closely with a multidisciplinary team, the candidate will engage in the design, analysis, documentation, and testing, orchestrating a symphony of innovation to meet our exacting standards and expectations of our bioprocessing customers.

Responsibilities

• Lead the design and development of innovative opto-mechanical products for Mid-IR spectroscopy, addressing the unique needs of PAT applications in biotechnology.
• Engage actively in new product development, collaborating closely with Software, Electrical, and Mechanical Engineering teams and external suppliers.
• Specify and procure optical components optimized for Mid-IR applications, ensuring compatibility and performance in real-time monitoring and control environments.
• Develop chemometric models for data analysis and interpretation, enhancing the utility and accuracy of PAT tools.
• Design and implement comprehensive test plans to verify the feasibility, design, operation, and performance of components and systems.
• Interface with service engineers, scientists, and suppliers.
• Collaborate with manufacturing and various engineering departments to develop test methods, criteria, and chemometric models for quality control and process optimization.
• Communicate with suppliers and vendors regarding drawing specifications, tolerance, and special process steps.
• Propose cost-saving initiatives on make-versus-buy analysis or alternative sourcing.
• Collaborate within multidisciplinary teams to contribute and achieve projects milestones or goals.

Qualifications

Education & Experience:

• BS/MS or higher in Systems Engineering, Mechanical Engineering, Physics, or related discipline.
• Solid background in optics and opto-mechanical systems with a spotlight on addressing Mid-IR technology challenges and requirements in the biotech sector.
• Deep understanding of Mid-IR spectroscopy and PAT applications, performance factors, incorporating knowledge of chemometrics and process modeling to enhance instrument performance and user application.
• Prior experience in the development of analytical instruments used in the life sciences (Preferred).
• Familiarity with system modeling and simulation tools, such as Matlab and Labview. 
• Experience in navigating and complying with regulated environments, including FDA, USP, EU, GMP, CE, and UL standards. 

Skills:

• A curious and analytical mindset, driven by a desire to contribute positively through technological innovation.
• Self-motivated with a positive attitude and a solid work ethic.
• Ability to analyze data, resolve issues, and think diagnostically.
• Strong communication skills, both penned and spoken, with a willingness to engage with different teams and customers.
• Ability to prioritize tasks and execute promptly to meet the deadlines.
• Experience with optical modeling software (Zemax preferred).
• Fluency in relevant technologies, application domains, and chemometric methodologies