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.

FUJIFILM Irvine Scientific, Inc. is a global leader in the innovation and manufacture of cell culture solutions for Life Science and Medical markets, providing products and services that assist customers in advancing healthcare initiatives. Working across discovery research, cell and gene therapy, reproductive medicine and cytogenetics, as well as the large-scale production of biotherapeutics and vaccines, the Company is trusted by researchers, manufacturers, and clinicians worldwide. For over 50 years, FUJIFILM Irvine Scientific’s Mission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in its products and custom solutions, providing customers with the vital resources needed to enrich human lives through innovative, accessible therapies. The Company’s facilities adhere to both ISO and FDA regulations, with manufacturing facilities that follow cGMP guidelines in the USA, Japan, and the Netherlands, and a media optimization center in China. All sites prioritize strategies that adhere to the FUJIFILM Sustainability Value Plan 2030 for sustainable growth. FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation reporting to FUJIFILM Holdings Corporation. 

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

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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.

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 (fisihr@fujifilm.com).