Manufacturing Process Engineer

Summary Manufacturing Process Engineer Billerica, MA (on-site) Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary Simoa® technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. With more than 3,400 peer-reviewed publications, Quanterix has been a trusted partner to the scientific community for nearly two decades. In 2025, Quanterix acquired Akoya Biosciences, The Spatial Biology Company®, adding multiplexed tissue imaging with single-cell resolution to its portfolio. Together, the combined company offers a uniquely integrated platform that connects biology across blood and tissue—advancing precision medicine from discovery to diagnostics. ROLE SUMMARY: The Manufacturing Process Engineer II is responsible for the technical ownership, performance, and continuous improvement of manufacturing processes. This role applies engineering principles to ensure processes are robust, scalable, and compliant while supporting safe and efficient manufacturing operations.

The Manufacturing Process Engineer II partners closely with Manufacturing, Quality, and R&D teams to support process troubleshooting, investigations, tech transfer, and process validation activities. This role is expected to identify process risks and improvement opportunities, develop technical solutions, and drive implementation through cross-functional collaboration.

What You’ll Do

• Serve as the technical owner for assigned manufacturing processes, with responsibility for process performance, robustness, and continuous improvement
• Monitor and analyze process performance and identify opportunities to improve yield, cycle time, robustness, and consistency
• Provide independent technical support and troubleshooting on the manufacturing floor as needed
• Define, maintain, and optimize process parameters and control strategies
• Lead troubleshooting and root cause analysis for complex or recurring process-related issues
• Lead deviation investigations, root cause analysis, and CAPA development related to process performance
• Assess product quality and process impact for deviations, process changes, and manufacturing events
• Lead or independently execute process improvement projects that enhance efficiency, safety, reliability, and process capability
• Use data analysis and trending to drive evidence-based improvements
• Lead or support process risk assessments (e.g., FMEA) for process changes and scale-up activities
• Author, review, and approve technical documentation
• Support or lead process tech transfer from development to manufacturing
• Support process characterization, PPQ, and ongoing process verification
• Collaborate with cross-functional teams to ensure successful scale-up and commercialization
• Partner with Manufacturing to ensure processes are executable and well-understood
• Collaborate with Manufacturing Engineering on equipment capability and process fit
• Work with Quality to support investigations, change controls, and regulatory readiness
• Identify opportunities to improve process documentation, standardization, and operational consistency
• Support all manufacturing production as necessary

BASIC QUALIFICATIONS:

• Bachelor’s degree in Chemical Engineering, Biomedical Engineering, or related engineering field with 6+ years of relevant experience, or a Master’s degree with 4+ years of relevant experience.
• Strong knowledge of chemical principles and laboratory techniques
• Experience leading or significantly contributing to process investigations, root cause analysis, and corrective/preventive actions
• Experience authoring and reviewing technical documentation
• Experience with tech transfer or scale-up activities
• Strong communication and collaboration skills
• Ability to work in a manufacturing environment with PPE requirements

PREFERRED QUALIFICATIONS:

• Problem-solving and process optimization skills
• Familiarity with safety protocols, and regulatory standards
• Experience supporting commercial manufacturing operations
• Familiarity with process validation lifecycle (PPQ, CPV)
• Knowledge of statistical data analysis and process trending
• Experience with Lean, Six Sigma, or other structured continuous improvement methodologies

EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES:- This position in on-site in Billerica, MA Travel

WHY YOU’LL LIKE WORKING FOR US: Our Technology From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Level of Quantification (LoQ). Our industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology, and infectious disease. Akoya Biosciences, a Quanterix company, is The Spatial Biology Company®—bringing tissue context to life through high-resolution, single-cell imaging. Akoya’s spatial phenotyping platforms help researchers visualize and measure how cells organize and interact within tissue to influence disease progression and therapeutic response. From discovery through clinical research, Akoya offers a full continuum of solutions, including PhenoCycler®, PhenoImager® Fusion and HT, and PhenoCode™ Panels. As part of Quanterix, Akoya complements a leading portfolio of ultra-sensitive biomarker detection technologies, together enabling a more complete view of biology and disease across both tissue and blood. Our Commitment to Employees: At Quanterix, our values are based on: Team , Innovation, Customer and Owner .

Team : Challenge assumptions, not the person. Respect diversity of thought and hold ourselves to lofty standards

Innovation : Stay curious, experiment, create and change

Customer : Prioritize and celebrate these pioneers by doing our best to deliver on commitments

Owner: Act with high integrity and in the best interest of Quanterix. Take measured risks and learn from their success and failures.

We reward and recognize our employees by offering competitive compensation and a 401k plan with employer match, as well as competitive health, dental, and vision benefits for employees and their dependents. We also offer an unlimited vacation policy to all exempt employees, and a generous PTO policy for non-exempt employees. All employees are eligible for equity, employee stock purchase plan, a performance bonus, and 1:1 financial counseling/planning. We also offer Tuition Assistance. We have a free, state-of-the-art onsite fitness center for all employees. To keep you fueled up, we provide onsite employees free snacks and drinks every day!

Diverse & Inclusive Workplace Quanterix is committed to a Diverse and Inclusive workplace. We strive to recruit candidates who will bring inclusive mindsets and contribute to our values.

Quanterix is an Equal Opportunity Employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status. Quanterix will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.