Senior Process Engineer, Assay Manufacturing Scale-Up

Quanterix

Billerica (MA)

On-site

USD 120,000 - 180,000

Full time

14 days+

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Benefits offered by this job

401k with employer match

Health, dental & vision benefits

Unlimited vacation policy

Generous PTO

Equity and stock purchase plan

Tuition assistance

Job summary

Quanterix seeks a Sr. Process Engineer - Assay Manufacturing in Billerica, MA. You will lead development, scale-up, and optimization of diagnostic assay manufacturing lines, bridging R&D and commercial production to ensure robust, scalable processes compliant with cGMP and ISO 13485.

You will troubleshoot complex issues, implement automation, and drive continuous improvement for high-quality diagnostic products while collaborating across functions for technology transfers and launches.

Qualifications

Bachelor's degree in Chemical Engineering, Bioengineering, Biotechnology, or a related scientific discipline. (Master's preferred).
Minimum 8 years of process engineering in a cGMP-regulated environment (IVD, medical device, or pharmaceutical).
Deep familiarity with FDA 21 CFR Part 820 and ISO 13485 requirements.

Responsibilities

Design, develop, and validate manufacturing processes for complex biological assays for scale-up to commercial production.
Ensure manufacturing activities comply with cGMP, FDA regulations, and ISO standards.
Lead IQ/OQ/PQ validation of automated liquid handlers and plate washers.
Troubleshoot process deviations, perform root-cause analysis, and implement CAPAs.
Author SOPs, Batch Records, Work Instructions, and validation protocols/reports.
Identify cost reductions and efficiency gains via Lean and Six Sigma, and pursue automation.
Collaborate with R&D, QA, and Supply Chain for tech transfers and launches.