Sr. Process Engineer

Bachelor’s or Master’s degree in Chemical Engineering, Biomedical Engineering, Biotech, or related field.
5+ years of experience in a regulated diagnostics or biomanufacturing environment, with at least 2 years specifically supporting LDTs or clinical lab workflows.
Strong knowledge of CLIA/CAP requirements and experience with quality systems and GMP/GLP.
Hands-on experience with lab automation platforms, liquid handling systems, and analytical instrumentation used in molecular diagnostics.
Strong Hamilton STAR method coding experience, with an emphasis on error handling and troubleshooting.
Demonstrated success leading cross-functional process improvement or technology transfer projects.
Proficiency in data analysis software (e.g., JMP, Minitab, Python, or Excel-based tools).
Excellent problem-solving, communication, and project management skills.

Lead process design, development, and optimization for LDT workflows, including sample prep, reagent handling, automation integration, and assay performance.
Act as a technical liaison between R&D and Operations to ensure smooth technology transfer from pilot to full-scale production.
Support validation activities including process qualifications (IQ/OQ/PQ), method validations, and equipment validations in accordance with CLIA, CAP, and FDA guidelines.
Develop and maintain process documentation including SOPs, batch records, protocols, and engineering reports.
Drive root cause analysis and implement corrective/preventive actions (CAPAs) for process deviations and non-conformances.
Collaborate with Quality Assurance and Regulatory Affairs to support audits, inspections, and continuous improvement initiatives.
Utilize statistical tools and data analysis (e.g., DOE, SPC, Six Sigma) to monitor process performance and identify opportunities for efficiency gains and cost reduction.
Support onboarding and training of junior engineers or technical staff as needed.