• Sr Validations Engineer

    Fujifilm (Santa Ana, CA)


    Position Overview

    We are hiring a Sr. Validations Engineer. The Sr. Validations Engineer will be responsible for performing validation activities related to processes, equipment, test methods, computerized systems, and facilities.

     

    Company Overview

     

    At FUJIFILM Irvine Scientific, we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world’s biggest health challenges.

     

    Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you’re ready to make an impact, your future belongs with us at FUJIFILM Irvine Scientific.

     

    Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide.

     

    Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

    Job Description

    Responsibilities

    + Develop and execute validation protocols associated with new products, equipment, systems, and processes used in the FUJIFILM Irvine Scientific facility.

    + Lead and support the execution of qualification/validation protocols (IQ/OQ/PQ/PV/CV/CSV), including the collection of samples, data, and completion of protocols.

    + Directly and indirectly compiles and analyzes validation data, prepares reports, and makes recommendations for changes and/or improvements, as applicable.

    + Ensures that Validation management is notified of deviations from protocol criteria, supports the identification of root causes and resolutions.

    + Support the investigation of deviations and problem-solving activities to identify root cause(s).

    + Coordinates the scheduling of protocol execution and testing with affected departments and personnel. This includes, but is not limited to: Manufacturing, Quality Assurance/Control, R&D and Facilities.

    + Lead and support the creation and review of SOPs.

    + Train equipment operators or other staff on qualification/validation/study protocols and standard operating procedures, as required.

    + Support the execution of commissioning protocols such as Factory Acceptance Testing (FAT) / Site Acceptance Testing (SAT), as applicable.

    + Lead and support the development of project plans and timelines.

    + Lead and support the tracking of project goals and work within cross-functional teams.

    + Provide guidance to the Validations Specialist(s) and oversee their activities, as requested.

    + May be required to perform other duties as assigned or as needed by Validation Manager.

    Required Skills/Education

    + BS in Bioengineering, Chemical Engineering, or equivalent.

    + **A minimum of 6+ years performing equipment/process/facility qualifications/validations in a medical device, pharmaceutical, or food manufacturing industry.**

    + 4+ years in a relevant validation role.

    + Process Engineering and Manufacturing Engineering experience beneficial.

    + Proficiency in Validation Specialist Level I and II functions.

    + Experience with SAP highly preferred.

    + Knowledge of study design (e.g., DOE).

    + Advanced knowledge of process validation, cleaning validation, and computerized system validation.

    + Advanced knowledge of equipment/system/facility qualification.

    + Knowledge of FDA/cGMP/QSR and associated guidelines relevant to validation.

    Salary and Benefits:

    + For California, the base salary range for this position is $103,093- $134,204. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).

    + Medical, Dental, Vision

    + Life Insurance

    + 401k

    + Paid Time Off

    *#LI-onsite

     

    EEO Information

     

    Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

     

    ADA Information

     

    If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).

     

    **Job Locations** _US-CA-Santa Ana_

    **Posted Date** _2 weeks ago_ _(5/13/2025 2:24 PM)_

    **_Requisition ID_** _2025-34366_

    **_Category_** _Validation_

    **_Company (Portal Searching)_** _FUJIFILM Irvine Scientific, Inc._