Technical Transfer Engineer
Bio-Techne
June 27, 2026
On-site
San Marcos, CA
Operations
Position Overview
The Tech Transfer Engineer transforms internally developed diagnostic products into fully defined, manufacturable, compliant production processes. Ensures procedures, batch records, and work instructions are clearly written, validated, and ready for manufacturing. Works with R&D, Manufacturing, Quality, and Program Management to move IVD calibrators, controls, and assays from development to customer release.
Key Responsibilities
- Translate R&D outputs into clear, detailed, compliant SOPs, batch records, and formulation/work instructions.
- Ensure documentation aligns with customer design requirements, performance specs, and regulatory constraints.
- Lead tech transfer for new products/processes into manufacturing (process flows, equipment needs, critical parameters, quality controls).
- Support training, engineering runs, pilot lots, OQ/PQ, and initial production batches.
- Standardize templates/documentation frameworks; define CPPs, in-process controls, and acceptance criteria.
- Serve as operational bridge across R&D, Manufacturing, QA/QC, and Program Management; contribute to customer meetings and timelines.
- Author/revise documents per GMP and ISO; support audits; manage revisions/change controls.
- Drive continuous improvement to reduce variability and update SOPs/batch records based on feedback, deviations, and CAPA.
Qualifications
- Bachelor’s in Biochemistry, Molecular Biology, Chemistry, Biomedical Engineering, or related field.
- 3–7 years in diagnostics/IVD manufacturing/biotech operations.
- Strongly preferred: experience writing SOPs/batch records/technical manufacturing documentation.
- Plus: IVD assay development, reagent formulation, or calibrator/control production.
Technical Skills
- Strong IVD manufacturing knowledge (reagent prep, filling, lyophilization if applicable, labeling, packaging).
- Statistical tools for process capability/quality control.
- Familiarity with ISO 13485, GMP/QSR, design control, ISO 14971 risk management.
- Exceptional technical writing; strong attention to detail; effective cross-functional communication; organized and able to manage multiple projects.
Benefits (examples)
- Competitive insurance starting day one (medical, dental, vision, life, short-term/long-term disability, pet, legal/ID shield).
- 401k, ESPP, HSA, FSA, Dependent Care FSA; mentorship, training, tuition reimbursement; paid leave/holidays and parental leave.
The Tech Transfer Engineer transforms internally developed diagnostic products into fully defined, manufacturable, compliant production processes. Ensures procedures, batch records, and work instructions are clearly written, validated, and ready for manufacturing. Works with R&D, Manufacturing, Quality, and Program Management to move IVD calibrators, controls, and assays from development to customer release.
Key Responsibilities
- Translate R&D outputs into clear, detailed, compliant SOPs, batch records, and formulation/work instructions.
- Ensure documentation aligns with customer design requirements, performance specs, and regulatory constraints.
- Lead tech transfer for new products/processes into manufacturing (process flows, equipment needs, critical parameters, quality controls).
- Support training, engineering runs, pilot lots, OQ/PQ, and initial production batches.
- Standardize templates/documentation frameworks; define CPPs, in-process controls, and acceptance criteria.
- Serve as operational bridge across R&D, Manufacturing, QA/QC, and Program Management; contribute to customer meetings and timelines.
- Author/revise documents per GMP and ISO; support audits; manage revisions/change controls.
- Drive continuous improvement to reduce variability and update SOPs/batch records based on feedback, deviations, and CAPA.
Qualifications
- Bachelor’s in Biochemistry, Molecular Biology, Chemistry, Biomedical Engineering, or related field.
- 3–7 years in diagnostics/IVD manufacturing/biotech operations.
- Strongly preferred: experience writing SOPs/batch records/technical manufacturing documentation.
- Plus: IVD assay development, reagent formulation, or calibrator/control production.
Technical Skills
- Strong IVD manufacturing knowledge (reagent prep, filling, lyophilization if applicable, labeling, packaging).
- Statistical tools for process capability/quality control.
- Familiarity with ISO 13485, GMP/QSR, design control, ISO 14971 risk management.
- Exceptional technical writing; strong attention to detail; effective cross-functional communication; organized and able to manage multiple projects.
Benefits (examples)
- Competitive insurance starting day one (medical, dental, vision, life, short-term/long-term disability, pet, legal/ID shield).
- 401k, ESPP, HSA, FSA, Dependent Care FSA; mentorship, training, tuition reimbursement; paid leave/holidays and parental leave.