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Biotech Process Engineer Jobs in Boston, MA (NOW HIRING)

Process Technology Engineer

Marlborough, MA ยท Hybrid

$95K - $120K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Join Sartorius as a Process Technology Engineer, supporting upstream and downstream bioprocess solutions across the full project lifecycle-from customer discovery through project execution. You will ...

Process Technology Engineer

Marlborough, MA ยท Hybrid

$95K - $120K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Join Sartorius as a Process Technology Engineer, supporting upstream and downstream bioprocess solutions across the full project lifecycle-from customer discovery through project execution. You will ...

Engineer II, Process Development

Norwood, MA ยท On-site

$74K - $118K/yr

  • PTO

This role is well suited for a proactive scientist or engineer who can independently plan and ... Experience/education in biotechnology process/product development. * Preferred: Hands on experience ...

Applications Engineer II

Boston, MA ยท On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

At PBS Biotech, we're not just building technology - we're helping bring life-changing therapies to ... Troubleshoot and resolve cell culture and process-related challenges in a timely manner * Provide ...

Applications Engineer II

Boston, MA ยท On-site

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

PBS Biotech is an innovative, fast-growing biotechnology company headquartered in Camarillo ... Troubleshoot and resolve cell culture and process-related challenges in a timely manner * Provide ...

Applications Engineer II

Brookline, MA ยท On-site

$109K - $131K/yr

PBS Biotech is an innovative, fast-growing biotechnology company headquartered in Camarillo ... Troubleshoot and resolve cell culture and process-related challenges in a timely manner * Provide ...

Showing results 21-40

Biotech Process Engineer information

See Boston, MA salary details

$53.8K

$100K

$154.8K

How much do biotech process engineer jobs pay per year?

As of Aug 15, 2026, the average yearly pay for biotech process engineer in Boston, MA is $99,968.00, according to ZipRecruiter salary data. Most workers in this role earn between $80,900.00 and $111,900.00 per year, depending on experience, location, and employer.

What is the difference between Biotech Process Engineer vs Biotech Manufacturing Technician?

AspectBiotech Process EngineerBiotech Manufacturing Technician
CredentialsBachelor's degree in biotech, chemical engineering, or related field; often requires experience in process designAssociate's or bachelor's degree; focus on operational skills and equipment handling
Work EnvironmentDesigning, optimizing, and overseeing production processes in labs or manufacturing facilitiesOperating and maintaining equipment on the manufacturing floor
Job FocusProcess development, scale-up, troubleshooting, and process improvementExecuting production tasks, quality checks, and equipment setup

Biotech Process Engineers focus on designing and improving manufacturing processes, requiring technical and analytical skills. In contrast, Biotech Manufacturing Technicians handle day-to-day production operations. Both roles are essential in biotech manufacturing but differ in responsibilities and required qualifications.

What are some common challenges faced by Biotech Process Engineers during scale-up from laboratory to production?

Biotech Process Engineers often encounter challenges when scaling up processes from laboratory or pilot scale to full production. These challenges can include maintaining product consistency, ensuring process sterility, and adapting equipment to handle larger volumes without compromising yield or quality. Engineers must also collaborate closely with cross-functional teams such as quality assurance, validation, and manufacturing to implement changes efficiently and adhere to regulatory standards. Proactive problem-solving and strong communication skills are key to overcoming these hurdles and ensuring successful technology transfer.

What does a Biotech Process Engineer do?

A Biotech Process Engineer designs, develops, and optimizes processes used in the production of biological products such as pharmaceuticals, vaccines, and biofuels. They work closely with scientists and manufacturing teams to scale up lab procedures to industrial levels while ensuring product quality and regulatory compliance. Their role often involves troubleshooting equipment, improving efficiency, and implementing new technologies within biotech manufacturing environments.

What are the key skills and qualifications needed to thrive as a Biotech Process Engineer, and why are they important?

To thrive as a Biotech Process Engineer, you need a solid background in chemical or biochemical engineering, process design, and regulatory compliance, typically supported by a relevant bachelor's or master's degree. Familiarity with process control systems, bioprocess simulation software, and industry-standard quality systems such as cGMP is essential. Strong analytical thinking, problem-solving abilities, and effective teamwork and communication skills help you excel in cross-functional environments. These skills ensure efficient, compliant, and innovative bioprocess operations, which are critical for product quality and organizational success.
Infographic showing various Biotech Process Engineer job openings in Boston, MA as of August 2026, with employment types broken down into 79% Full Time, and 21% Contract. Highlights an 79% In-person, 7% Hybrid, and 14% Remote job distribution, with an average salary of $99,968 per year, or $48.1 per hour.

Sr. Process Engineer - Assay Manufacturing

QUANTERIX CORP

Billerica, MA โ€ข On-site

$100K - $120K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 4 days ago


Job description

Sr. Process Engineer - Assay Manufacturing
Billerica, MA
Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs in disease research, diagnostics, and drug development. Its proprietary Simoaยฎ 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 Companyยฎ, 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:
We are seeking a highly skilledSr. Process Engineer - Assay Manufacturing to lead the development, scale-up, and optimization of our diagnostic assay manufacturing lines. The ideal candidate will bridge the gap between R&D and commercial production, ensuring that all manufacturing processes are robust, scalable, and fully compliant with cGMP and ISO 13485 standards. You will be responsible for troubleshooting complex technical issues, implementing automation, and driving continuous improvement to ensure the highest quality of our diagnostic products.
WHAT YOU'LL DO:
  • Process Development & Scale-Up: Design, develop, and validate manufacturing processes for complex biological assays, moving products from R&D prototypes to full-scale commercial production.
  • cGMP Compliance: Ensure all manufacturing activities, equipment, and documentation strictly adhere to current Good Manufacturing Practices (cGMP), FDA regulations, and ISO standards.
  • Equipment Validation (IQ/OQ/PQ): Lead the installation, operational, and performance qualification of automated liquid handlers, plate washers, and other specialized assay manufacturing equipment.
  • Technical Troubleshooting: Act as the subject matter expert (SME) for root-cause analysis of process deviations and yield excursions. Implement effective Corrective and Preventive Actions (CAPA).
  • Documentation: Author and review Standard Operating Procedures (SOPs), Batch Records, Work Instructions, and Process Validation protocols/reports.
  • Continuous Improvement: Identify opportunities for cost reduction and efficiency gains through Lean Manufacturing, Six Sigma methodologies, and the integration of new technologies or automation.
  • Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, and Supply Chain to ensure seamless technology transfers and product launches

BASIC QUALIFICATIONS:
  • Education: Bachelor's degree in Chemical Engineering, Bioengineering, Biotechnology, or a related scientific discipline. (Master's preferred).
  • Experience: Minimum 8 years of experience in a process engineering role within a cGMP-regulated environment (e.g., IVD, medical device, or pharmaceutical industry).
  • Regulatory Knowledge: Deep familiarity with FDA 21 CFR Part 820 and/or ISO 13485 requirements.
PREFERRED QUALIFICATIONS:
  • Direct experience with assay chemistry, reagent formulation, or diagnostic kit assembly
  • Hands-on experience with automated manufacturing platforms and liquid handling systems
  • Strong understanding of Statistical Process Control (SPC) and Design of Experiments (DoE).
  • Experience with Six Sigma or Lean Manufacturing certification (Green/Black Belt).
  • Proficiency in statistical software such as Minitab or JMP.
  • Background in lyophilization processes or coating technologies.
  • Strong project management skills and the ability to lead cross-functional teams.

EXPECTATIONS, COMPETENCIES, SKILLS & ABILITIES:
  • Strong judgment, accountability, and attention to detail in a regulated manufacturing environment.
  • Effective communication and collaboration across technical and cross-functional teams.
  • Strong problem-solving and decision-making skills with the ability to assess risk and recommend practical solutions.
  • Ability to manage multiple priorities, adapt to changing business needs, and meet deadlines.
  • Professionalism, sound judgment, and the ability to handle sensitive information with discretion.
  • Continuous learning mindset with a focus on quality, process improvement, and operational excellence.
  • Must be able to work in a cleanroom environment (ISO 7/8).
  • Occasional lifting of equipment (up to 25 lbs) may be required.
  • Adherence to strict gowning and safety protocols is mandatory.
  • Work location: Billerica, MA (Onsite 5 days)
  • Travel 10%
WHY YOU'LL LIKE WORKING WITH US:
Our Technology:
From discovery to diagnostics, Quanterix's ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. Simoaยฎ 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 Companyยฎ-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 PhenoCyclerยฎ, PhenoImagerยฎ Fusion and HT, and PhenoCodeโ„ข 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.
Pay Range: $100,000 - $120,000 per year