Process Engineer -IVD

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Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. 

Your Role:

The Process Engineer is responsible for the development, optimization, and implementation of manufacturing processes within an organization. The successful candidate will be part of a team of process engineers, ensuring collaboration across various departments, such as R&D, production, and quality assurance. Key responsibilities include managing projects, assisting team members when needed, troubleshooting process issues, ensuring compliance with industry standards, and utilizing data analytics for performance monitoring and improvement. This role supports the manufacture of regulated in vitro diagnostic (IVD) products within a Quality Management System (QMS), ensuring process compliance, validation, and robust product quality.
 

Responsibilities:

• Lead the design, implementation, and refinement of manufacturing processes to maximize operational efficiency, minimize costs, and ensure superior product quality.
• Ensure all processes adhere to IVD regulations and safety standards, managing critical documentation for IQ/OQ/PQ validation, risk management, and lifecycle controls.
• Partner closely with R&D, Production, and Quality Assurance to facilitate the seamless transition of new products and processes into a manufacturing environment.
• Oversee engineering projects from initial conception through final execution, ensuring strict adherence to established timelines, budgets, and technical specifications.
• Identify and resolve complex process deviations and equipment issues, implementing effective Corrective and Preventive Actions (CAPA) to maintain continuity.
• Utilize advanced data analytics and process simulation tools to monitor performance trends and drive continuous improvement initiatives.
• Drive a culture of technical excellence by training and mentoring team members in industry best practices, safety guidelines, and professional development standards.

Who You Are

Minimum Qualifications:

• Bachelor's Degree in Engineering (Chemical, Mechanical, or Industrial, etc.).
• 3+ years of experience in process engineering, with a focus on manufacturing processes.

Preferred Qualifications:

• Lean Six Sigma training (Blue, Green or Black belt).
• Experience supporting tabletting processes (e.g., blending/granulation, compression, in-process controls, troubleshooting).
• Experience supporting process/equipment validation in a regulated environment (e.g., IQ/OQ/PQ, PPQ), including execution support, deviation handling, and documentation within a QMS (change control, CAPA).
• Leadership experience
• Proficiency in process simulation software, data analysis tools, and project management software.
• Strong analytical skills and the ability to troubleshoot complex engineering problems.
• Excellent verbal and written communication skills to effectively collaborate with team members and stakeholders.

RSREMD

• Pay Range for this position: $68,100.00- $102,100.00.
• The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!