Validations Engineer

Fujifilm•Santa Ana, CA

3d•Onsite

About The Position

We are hiring a Validations Engineer. The Validations Engineer will be perform validation activities related to processes, equipment, test methods, computerized systems, and facilities. At FUJIFILM Biosciences, 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 Biosciences. 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.”

Requirements

BS in Bioengineering, Chemical Engineering, or equivalent.
A minimum of 2+ years performing equipment/process/facility qualifications/validations in a medical device, pharmaceutical, or food manufacturing industry.
Knowledge of study design (e.g., DOE).
Knowledge of process validation, cleaning validation, and computerized system validation.
Knowledge of equipment/system/facility qualification.
Knowledge of FDA/cGMP/QSR and associated guidelines relevant to validation.
Ability to speak, read, and write English proficiently.
Proficient oral and written communication skills.

Nice To Haves

Process Engineering and Manufacturing Engineering experience beneficial.

Responsibilities

Develop and execute validation protocols associated with new products, equipment, systems, and processes used in the FISI facility.
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.
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.
Support the development of project plans and timelines.
Work within cross-functional teams.
May be required to perform other duties as assigned or as needed by Validation Manager.