- 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.
- Define and develop test systems in the lab. Ensure that all test systems and equipment are ap-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.
- 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
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Engineer, Verification - San Diego, United States - GRIFOLS, S.A.
Description
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
Summary:
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
Minimum requirement: Bachelors Degree in a technical discipline such as Engineering (Computer, Electrical, Chemical, etc), Life Sciences or equivalent.
Experience:
5+ yrs experience in verification or validation
4+ yrs experience with product development or GMP
Equivalency:
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.
Pay Scale:
The estimated pay scale for Engineer, Verification and Validation role based in San Diego, California, is $93,435 to $116,794 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. 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.
Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg
Learn more about Grifols
Engineer, Verification professionals in San Diego
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Naveen Desai
Synthesis/STA/Physical Design Engineer