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Technical Transfer Engineer

San Marcos, CA, US • Posted 12 days ago • Updated 5 days ago

Full Time

On-site

USD $73,100.00 - 120,200.00 per year

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Job Details

Skills

Research
Life Sciences
Product Design
Technology Transfer
Process Flow
Training
Workflow
Technical Support
OQ
PQ
Process Modeling
Process Control
Usability
Quality Assurance
Program Management
Resource Planning
Regulatory Compliance
Auditing
Document Management
Continuous Improvement
Clarity
Operational Efficiency
Corrective And Preventive Action
Biochemistry
Molecular Biology
Chemistry
Biomedical Engineering
Writing
Manufacturing
Quality Control
ISO 13485
GMP
Design Controls
Risk Management
ISO 9000
Assays
Technical Writing
Documentation
Attention To Detail
Collaboration
Research and Development
Organized
Management
Insurance
Legal
Finance
FSA
Mentorship
Training And Development
Innovation

Summary

By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Pay Range:
$73,100.00 - $120,200.00
By joining Bio-Techne, you'll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Position Overview

The Tech Transfer Engineer is responsible for transforming internally developed diagnostic products into fully defined, manufacturable, and compliant production processes. This role focuses heavily 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.

Key Responsibilities

Operationalization of Development Outputs

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.

Technology Transfer to Manufacturing

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.

Process Definition & Standardization

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.

Cross-Functional Collaboration

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.

Compliance & Documentation Control

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.

Continuous Improvement

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

Education & Experience

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.

Technical 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.

Why Join Bio-Techne:

We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
We invest in our employees' financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

Bio-Techne is an E-Verify Employer in the United States.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: RTX1e4209
Position Id: 3ebb30d5566ed688c41ccbd87b65886f
Posted 12 days ago

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