Thermo Fisher Scientific is looking for a talented, versatile engineer or scientist to lead design verification and validation (V&V) activities for life science systems comprised of instruments, software, consumables, assays, cells, culture system and reagents.
Primary Duties and Responsibilities
- Leads, delegates and guides the verification and validation resource team to drive efficient and effective delivery of activities in the product commercialization process.
- Manages day to day activities of V&V team members
- Works with the development team of engineers and/or scientists to plan and execute verification and validation testing of commercial product designs.
- Oversees ad-hoc testing to support pre-verification V&V activities.
- Participates in drafting customer/product requirements, specifications and design inputs. Work with Design Compliance and Quality to drive harmonization and standardization in associated processes.
- Participates in the generation of instrument- and/or software-based measurement tools to aid with V&V activities.
- Creates detailed test protocols from product specification document or high-level plan.
- Oversee V&V team in the generation of test plans, executing tests, performing data analysis, and writing reports.
- Participates in transferring test protocols to manufacturing/operations partners.
- Develop and institute processes to facilitate V&V best practices in research and therapeutic application product designs.
- Generate and distribute monthly and quarterly V&V project tracking reports for senior management team
Skills & Education
- Strong background in statistics.
- Demonstrated skills in project management.
- Experience working in a product development environment
- Experience working in a regulated environment
- Demonstrated ability to work with a diverse team of R&D, Quality and Design Compliance resources
- At least 5 years of V&V experience with complex life science systems and assays.
- Experience in executing formal V&V testing and informal ad-hoc testing.
- Knowledge of Quality by Design (QBD) principles and ICH standards for assay validation .
- PhD + in engineering, quantitative biology, or related scientific or an engineering field + 7 years industry experience, or MS + 10 yrs. Experience, or B.S + 15 years experience.
- Deployed and maintained formal processes (i.e. verification, validation)
- Familiarity with cell culture, genomic and device technologies.
- Data analysis, script programming, and visualization with JMP statistical software system.
- Familiarity with and deployment of Design Excellence tools in product development process.
- People leadership experience