Grifols Shared Services North America, Inc Engineer, Verification and Validation in Emeryville, California
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
The Engineer, Verification and Validation (V&V) will be engaged in verifying and validating product designs according to FDA requirements and internal quality standards. The incumbent will provide input to what is required to show compliance, including the amount of data required and the methodologies for collecting and analyzing the data. The incumbent ensures that the data is collected using devices and software of appropriate recorded configurations, performs the required analyses, and documents work to meet standards and project delivery commitments.
Primary responsibilities for role:
●Works closely with Systems Engineering, Project Management, Marketing, Quality and Regulatory personnel to verify and validate products.
●Implement project verification and validation strategies by defining and delivering verification and validation project deliverables.
●Work with project teams to create, review, and approve verification and validation deliverables.
●Review use cases and requirements for products to ensure that requirements and specifications can be verified and validated, including risk mitigations, usability and regulatory requirements.
●Work with product development teams to understand the product configurations being developed.
●Identify the data that will be required to show objectively that all configurations of the product meet their requirements, as well as the customer needs.
●Define and develop test systems in the lab. Ensure that all test systems and equipment are appropriately validated and controlled.
●Perform verification and validation testing.
●Review and analyze test data and record pass/fail results and conclusions. Ensure that testing and results are traced to requirements.
●Track and report on progress toward completion of verification and validation.
●Summarize the verification and validation performed, the data reviewed, and conclusions reached.
●Project deliverables may including producing and/or reviewing verification and/or validation plans, protocols, and reports; execution of the plans and protocols; and resolving deviations.
●Manage timeline for verification and validation activities and provide updates to project teams.
●Support systems engineering teams in the completion of development testing, to characterize designs and understand trade-offs.
Completion of verification and validation plans, protocols and reports within assigned target dates, including oversight of testing activities.
Successful execution of study protocols.
Successful management of V& V related activities and timelines associated with completion of Grifols Projects.
Knowledge, Skills, and Abilities:
Experience executing verification and validation plans, and protocols
Experience with requirements management, risk based testing approaches, defect tracking, and configuration control tools
Understand good engineering practices and test methodologies
Demonstrated capability to solve technical and scientific problems
Medical equipment or other equipment experience involving complex, multi-component systems, including lab automation
Familiar with engineering process improvement methodologies
Manage multiple tasks and priorities simultaneously and adapt to changes in program priorities
Excellent communication and interpersonal skills
Minimum requirement: Bachelors Degree in a technical discipline such as Engineering (Computer, Electrical, Chemical, etc), Life Sciences or equivalent.
5+ yrs experience in verification or validation
4+ yrs experience with product development or GMP
EEO Minorities/ Disability/Veterans
Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Req ID: 273141