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Process Engineer
1 month ago
Job Summary:
We are seeking a highly motivated Process Engineer to join our Accelerator Team in Billerica, MA. The successful candidate will play a crucial role in ensuring the robust transfer of Laboratory Developed Tests (LDT) and In Vitro Diagnostic (IVD) assays from the Accelerator team to pilot/manufacturing team prior to regulatory submission.
Key Responsibilities:
Process Development and Optimization:
Drive new product introductions (NPI) to manufacturing through assessment of raw materials, drafting of work instructions, and manufacture of pilot scale assay reagents
Collaborate with R&D and manufacturing teams to understand assay requirements and design specifications.
Develop and optimize processes for the efficient and reproducible transfer of assays from Accelerator to manufacturing.
Technical Transfer:
Work closely with the Project Management and Scheduler to review manufacturing requirements and generate build plans, establish priorities, resolve problems, and report results
Lead the technical transfer of LDT/IVD assays to pilot/manufacturing, including documentation, training, and troubleshooting.
Develop detailed process transfer protocols, standard operating procedures (SOPs), and batch records.
Perform batch record reviews for manufacturing records, complete/review Syteline ERP transactions for associated job orders
Participate in inventory control and replenishment, interfacing with area managers and other manufacturing technicians
Plan and execute process validation and verification activities to demonstrate the robustness and reproducibility of transferred assays
Continuous Improvement:
Drive lean manufacturing efforts, process improvements, regulatory compliance & quality improvement projects, cost reduction efforts, capacity planning, organizational development and supply chain initiatives to enhance efficiency, yield and quality
Participate in documentation, design reviews, risk assessments and other process improvements, investigations and resolutions of product/process issues
Stay updated with industry trends and technological advancements to incorporate best practices into process development and transfer
Documentation and Compliance:
Initiate, investigate & close quality systems (deviation, NCMR, CAPA, change control)Ensure all process documentation is accurate, complete, and compliant with regulatory standards (e.g., FDA, ISO).
Support regulatory submissions and inspections, as required.
Requirements:
BASIC QUALIFICATIONS:
Bachelor's degree in Engineering, Biotechnology or Biochemistry with 2+years of experience in Process Engineering OR a Master's degree in Engineering, Biotechnology or Biochemistry with 0-2 years of process engineering experience.
PREFERRED QUALIFICATIONS:
5+ years of experience transferring medical devices to manufacturing is preferred
Demonstrated experience with successful medical device manufacturing transfer to support regulatory submission (21 CFR 820).
Demonstrated ability to Transfer Design to support new product launches.
Previous experience with automation and high-throughput screening
Excellent problem-solving skills and attention to detail.
Strong communication and interpersonal skills, with the ability to work effectively in cross-functional teams.
Experience with process validation, statistical analysis, and continuous improvement methodologies.
Familiar with electronic document management systems, i.e. MasterControl, Arena
Familiar with CLSI Guidelines
Proficiency in statistical software (e.g. JMP, Minitab)
Knowledge of regulatory requirements and standards (e.g., FDA, ISO 13485, ISO is highly desirable.
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.
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.
Our Values:
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 dayDIVERSE & 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.#LI-Onsite #LI-JC2
