Validation Specialist

BioLegend develops world-class, cutting-edge antibodies and reagents for biomedical research, manufactured in our state-of-the-art facility in San Diego, CA. Our mission is to accelerate research and discovery by providing the highest quality products at an outstanding value, along with superior customer service and technical support. Our product expertise covers a diverse set of research areas including Immunology, Neuroscience, Cancer, Stem cells, and Cell Biology. 

Job Summary

The Operations Validation Specialist at BioLegend will perform and administer validation activities associated with equipment, processes, test methods, facilities and software/systems, in accordance with Biolegend’s Vision, Mission, Quality Policy, and Quality Objectives for implementation, maintenance and improvement of BioLegend's Quality Management System (QMS).

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ensure that all equipment related to the production of BioLegend products is installed and operates in manner that consistently produces products that meet established specifications. Ensure that all processes are reliable and repeatable in meeting required quality attributes and established specifications.
• Where deficiencies exist or improvements are needed – lead and/or support process or laboratory owners in developing, executing, and documenting the required validation improvements in a way that supports both the pragmatic short-term needs of the business and minimum regulatory requirements, while also supporting the long-term needs for a timely, robust, and flexible program that meets necessary regulatory and policy requirements.
• Lead, participate, and execute a wide range of validation activities such as equipment, processes, methods, and software validation to ensure compliance with the applicable regulations (GMP and/or ISO 13485), corporate policies, and Standard Operating Procedures that govern the production of product, process development, and/or research activities. This equipment may include systems designed to deliver clean water, steam, environmental conditions, a wide variety of process equipment and storage units (refrigerators, freezers, incubators, etc.) as well as shipping processes.
• Validation activities will include the generation, completion, and approval of all relevant documentation including Installation, Operation, and Performance Qualification protocols, reports, SOP’s, training materials, deviations, discrepancy reports and revision to production documents and testing forms.
• Validation activities will include the operation of a wide range of standard and complex laboratory and production equipment including spectrophotometers, centrifuges, autoclaves, lyophilizers, and chromatography systems. Data collection systems for temperature, humidity, pressure, pH, conductivity, UV-Vis, and CO₂ will be used with commercial statistical analysis software (Excel, Mini-Tab, JMP) for data evaluation.
• In addition to active participation in the validation of equipment, processes, methods, and software the Validation Specialist will also be required to perform routine and periodic requalification of current equipment including all relevant documentation and necessary changes to SOPs and/or operating instructions.
• Indirect validation activities will include support of internal and external audits, troubleshooting and process improvement for equipment and processes, CAPA investigations, root cause analysis and general support of non-conforming events using industry standard tools such as fishbone diagrams and 5 Why analysis
• Contribute to the generation and review of required documentation that support the validation lifecycle requirements. Create, review, and approve QMS documentation.
• Support change control, Engineering control, new product and validations (equipment, methods and processes), and risk management.
• Assure products (current and new), materials and process, including their applicable documentation, are complaint with applicable QMS requirements.
• Support the QMS training program, including ISO13485, and regulatory requirements, and act as a resource to ensure quality compliance.
• Support customer, supplier, and regulatory audits, including timely document search and delivery during audits, as necessary.
• Support Management Review with metrics data on Quality processes.
• Perform other work as assigned

iACT Competencies

• innovate – Be better, keep improving, be more efficient, creative, and be in the forefront of development
• Aspire – Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights
• Collaborate – Foster teamwork, common goals, selflessness, communication and mutual support
• Transform – Adapt, learn, re-invent and change for future development and growth

Minimum Qualifications – Education and Experience

• Bachelor’s Degree in Biology or a related field or an equivalent combination of education and experience
• 2 years progressively responsible validation experience in the pharmaceutical or biotech industry with Knowledge of GMP regulations.
• 3 years of experience with quality assurance procedures under ISO 13485, cGMP, or ISO 9001 standards.
• Thorough working knowledge of QMS documentation requirements.
• Excellent data management and analytical skills
• Strong communication skills - written, verbal and computer
• Experience with MS Word, Excel, Power point, Visio, Adobe Acrobat and ERP systems

Preferred Qualifications – Education and Experience

• Experience with electronic document control systems

Condition of Employment

Concerns regarding COVID-19 continue as positive cases are experienced in the communities in which we operate. Please be aware that, as a condition of employment, BioLegend requires proof of COVID vaccination for all U.S.-based employees (subject to limited exceptions) beginning January 18, 2022.