Process Engineer III/Sr Process Engineer - Enumerix

Join the Genomics Revolution!

Are you ready to lead the charge in one of the most groundbreaking revolutions in genomics? Enumerix is on the lookout for an energetic and experienced process engineer to join our mission in launching the revolutionary UltraPCR™ platform. This platform, a culmination of advancements in molecular biology, emulsion chemistry, consumables, 3D imaging, and computational imaging, stands as a next-generation PCR platform with unparalleled precision and accuracy in quantifying single molecules in a highly multiplexed manner.

Why Enumerix? At Enumerix, we're not just developing products; we're shaping the future of genomics. Our executive team, comprising pioneers in the genomics space, has a rich history of inventing and building products such as microarray, NIPT, single cell, and spatial genomics. Leveraging this wealth of experience, we believe we can now disrupt the stagnant field of PCR that has seen minimal innovation for many years. Join us and be part of a dynamic, interdisciplinary team at the forefront of innovation.

Your Role:

• Drive the process development to optimize, scale up, and automate the manufacturing of UltraPCR reagents and to reduce the reagent COGS.
• Develop appropriate quality control (QC) implementations throughout the manufacturing process (e.g., IQC of critical raw materials, PQC after key manufacturing processes, and OQC of finished products, etc.) to ensure product quality.
• Ensure EH&S Compliance for all manufacturing processes.
• Maintain thorough documentation of manufacturing and QC work instructions/SOP that align with Enumerix's QA/QC system.
• Drive the product integration testing and system verification and validation (V&V) to support product launch.
• Support early-stage reagent pilot productions and facilitate reagent manufacturing transfer during late-stage product development.
• Mentor junior team members and provide technical expertise in process engineering.
• Uphold the highest standards by adhering to all company policies and health and safety codes.

Your Profile:

• Hold a Bachelor's degree or higher in Chemical Engineering, Bioengineering, Biomedical Engineering, or other relevant disciplines.
• Possess at least 3 years of industry experience in the field of process engineering, particularly in reagent development and manufacturing for biotechnology, diagnostics, and pharmaceutics.
• Demonstrate strong problem-solving and analytical skills, including root cause analysis (RCA), failure modes effect analysis (FMEA), and data-driven decision-making.
• Exhibit excellent teamwork and communication skills.
• Possess knowledge of statistical tools and data analysis software, which is strongly desirable.
• Have familiarity with hazard communication programs, safety data sheets (SDS), labeling, storage, and handling of chemicals, which is desirable.
• Possess a basic understanding of molecular biology, biochemistry, and genomics.
• Demonstrate proficiency in Lean/Six Sigma methodologies and process optimization, which is preferred.
• Possess experience with regulatory compliance standards (e.g., ISO 13485), which is preferred.

For this position, the base pay range is: $75,000-$130,000 per year. Please apply directly on our company website www.enumerix.com.
Enumerix is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Direct applicants only, no recruiters please.