Requirements for the Senior Validation Scientist - IVD:
- Bachelor's degree in relevant life science discipline, chemistry or engineering. Advanced degree preferred.
- 6+ years' experience in manufacturing, process development, quality control or quality assurance in pharmaceuticals or medical devices.
- Extensive experience in IVD - medical device validation, including molecular method and process validation.
- In-depth technical knowledge in genomics, protein analysis, or cellular analysis as evidenced by peer-reviewed publications.
- Equipment qualification - IQ OQ PQ - of equipment used to manufacture medical devices
- Demonstrated experience in molecular method validation and process validation including filling, packaging and other manufacturing.
- Proven ability to work cross functionally, problem solve and embrace conflict to negotiate compromise.
- Exercise judgment in selecting methods, techniques and evaluation criteria for obtaining results.
- Lead teams or projects as assigned.
Responsibilities for the Senior Validation Scientist - IVD:
- Support QSR compliant manufacturing through the implementation and coordination of validation activities.
- Establish and develop procedures and protocols for validating equipment, processes and QC methods.
- Write and review product master validation plans, qualification protocols, and associated reports.
- Review and approve batch records, stability data, and validation results to ensuring products meet requirements and corresponding documentation is accurate and consistent.
- Assess nonconforming product situations; approve disposition plans of inventory product on hold, and assist in the planning for nonconforming product in branch inventories.
- Write SOP's.
- Understand and comply with applicable regulatory requirements.
Occupational Category: 19-1020 Biological Scientists