Sr. Manager, Verification & Validation
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
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.