Engineer, Verification and Validation

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care. Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries. A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.

Summary:

Planning and performing laboratory experiments to develop and optimize formulations and manufacturing processes. Generation and testing of formulations in support of biological evaluation ( in vitro and in vivo ) of prototype and optimized formulations.

Primary Responsibilities for the 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 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 include 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.                                                               

Additional Responsibilities:

• 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.

Education:

Minimum requirement: Bachelor’s Degree in a technical discipline such as Engineering (Computer, Electrical, Chemical, etc.), Life Sciences or equivalent.            

Experience:

5 plus yrs. experience in verification or validation.

4 plus 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.    

Occupational Demands:

Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.   Frequently walks.  Occasionally bends and twists neck.  Light to moderate lifting and carrying objects with a maximum lift of 25lbs.  Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.  Frequently interacts with others, relates sensitive information to diverse groups.  Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.                                  

More about us, benefits we provide you:

• salary in line with the market as well as an annual bonus target
• flexible working hours, 80% on site and 20% remote
• free parking
• Professional development opportunities (training, career development)
• Gym pass, Employees perks program
• 401 (K) Retirement Plan (Grifols will match 100% on the first 4% of eligible compensation you contribute, and 50% on the next 2% of eligible compensation you contribute)
• Health insurance: Medical, Dental, Vision
• Travel accident insurance, Life and AD and D Insurance
• Short- & Long-Term Disability Insurance
• Health Savings Account, Flexible Spending Account
• Critical Illness, Accident, Hospital Indemnity coverages
• Adoption Assistance
• Employee assistance plan

Pay Scale:

The estimated pay scale for Engineer, Verification and Validation role based in San Diego, California, is $91,313 to $136,970 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!

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.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.

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Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg 

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