Manufacturing Process Engineer II – Onsite Impact

Quanterix; Billerica (MA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Unlimited vacation

401k with employer match

Health, dental & vision benefits

Equity and Employee Stock PurchasePlan

Tuition assistance

Onsite fitness center

Free snacks and drinks

Job summary

Quanterix in Billerica, MA is seeking a Manufacturing Process Engineer II to own and improve critical biomanufacturing processes. You will partner with Manufacturing, Quality, and R&D to troubleshoot, transfer tech, validate processes, and drive CAPA with cross-functional teams.

You will define process parameters, monitor performance, lead root‑cause analyses, and author technical docs while ensuring safety and regulatory readiness.

Qualifications

• Bachelor's in Chemical Engineering, Biomedical Engineering, or related field with 6+ years of experience, or a Master's with 4+ years of experience.
• Strong knowledge of chemical principles and laboratory techniques.
• Experience leading process investigations, root cause analysis, and CAPA.
• 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.

Responsibilities

• Serve as technical owner for assigned manufacturing processes, with responsibility for performance and continuous improvement.
• Monitor and analyze process performance to improve yield, cycle time, robustness, and consistency.
• Provide on-floor technical support and troubleshooting.
• Define, maintain, and optimize process parameters and control strategies.
• Lead troubleshooting and root cause analyses for complex issues.
• Lead deviation investigations and CAPA related to process performance.
• Lead or execute process improvement projects to enhance efficiency, safety, and process capability.
• Use data analysis and trending to drive improvements.
• Lead or support process risk assessments (e.g., FMEA) for changes and scale-up.
• Author, review, and approve technical documentation.
• Support or lead process tech transfer from development to manufacturing.
• Support process characterization, PPQ, and ongoing verification.
• Collaborate with cross-functional teams for scale-up and commercialization.

Skills

Strong communication

Collaboration

Problem solving

PPE compliance

Education

Bachelor's degree in Chemical Engineering or Biomedical Engineering

Master's degree in Chemical Engineering or Biomedical Engineering

Job description

Quanterix in Billerica, MA is seeking a Manufacturing Process Engineer II to own and improve critical biomanufacturing processes. You will partner with Manufacturing, Quality, and R&D to troubleshoot, transfer tech, validate processes, and drive CAPA with cross-functional teams.

You will define process parameters, monitor performance, lead root‑cause analyses, and author technical docs while ensuring safety and regulatory readiness.