Technical Transfer Engineer

Role Summary

The Tech Transfer Engineer is responsible for transforming internally developed diagnostic products into fully defined, manufacturable, and compliant production processes. This role focuses on operations, ensuring that all procedures, batch records, and work instructions are clearly written, validated, and ready for seamless execution on the manufacturing floor. Working closely with R&D, Manufacturing, Quality, and Program Management, this person ensures that IVD calibrators, controls, and diagnostic assays move smoothly from development through production and ultimately to customer release.

Responsibilities

• Translate R&D development work into clear, detailed, and compliant work instructions, batch records, formulation instructions, and work instructions.
• Ensure all operational documentation reflects customer product design requirements, performance specifications, and regulatory constraints.
• Identify manufacturability gaps early and collaborate with R&D to refine processes for operational efficiency and robustness.
• Lead the tech transfer process of new products and processes from development into manufacturing.
• Develop comprehensive tech transfer packages including process flows, equipment needs, critical parameters, and quality controls.
• Support training of manufacturing personnel on new SOPs, workflows, and product-specific handling requirements.
• Support engineering runs, pilot lots, OQ/PQ and initial production batches to confirm documentation accuracy and process readiness.
• Create standardized templates and documentation frameworks to streamline future tech transfers.
• Define critical process parameters, in-process controls, and acceptance criteria in collaboration with R&D and Quality.
• Ensure all operational documents are optimized for clarity, usability, and compliance.
• Serve as the operational bridge between R&D, Manufacturing, Quality Assurance, Quality Control, and Program Management.
• Participate in customer meetings to clarify design intent, operational constraints, and documentation expectations.
• Provide input on project timelines, resource planning, and manufacturability considerations.
• Author and revise work instructions, batch records, and technical reports in compliance with GMP and ISO standards.
• Support internal and external audits on tech transfer by providing accurate, up-to-date operational documentation.
• Maintain document control discipline, ensuring revisions, approvals, and change controls are properly executed.
• Identify opportunities to improve process clarity, reduce variability, and enhance operational efficiency.
• Drive updates to tech transfer SOPs and new product batch records based on production feedback, deviations, and CAPA outcomes.
• Contribute to the development of best practices for documentation, tech transfer, and operational readiness.

Qualifications

• Bachelor’s degree in Biochemistry, Molecular Biology, Chemistry, Biomedical Engineering, or related field.
• 3–7 years of experience in diagnostics, IVD manufacturing, or biotech operations.
• Experience writing SOPs, batch records, or technical manufacturing documentation is strongly preferred.
• Background in IVD assay development, reagent formulation, or calibrator/control production is a plus.

Skills

• Strong understanding of IVD manufacturing processes, including reagent preparation, filling, lyophilization (if applicable), labeling, and packaging.
• Experience with statistical tools for assessing process capability and quality control.
• Familiarity with ISO 13485, GMP/QSR, design control, and risk management (ISO 14971).
• Ability to interpret development data, customer requirements, and assay performance characteristics to define operational processes.
• Exceptional technical writing and documentation skills.
• Strong attention to detail and commitment to accuracy.
• Effective communicator who can collaborate across R&D and operations.
• Organized, proactive, and comfortable managing multiple projects in parallel.