Validations Engineer

Position Description

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

• 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 compile and analyze validation data, prepare reports, and make recommendations for changes and/or improvements, as applicable.
• Ensure that Validation management is notified of deviations from protocol criteria, and support the identification of root causes and resolutions.
• Support the investigation of deviations and problem‑solving activities to identify root cause(s).
• Coordinate the scheduling of protocol execution and testing with affected departments and personnel, including, but 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 the Validation Manager.

• 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.
• Process Engineering and Manufacturing Engineering experience beneficial.
• 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.

• For California, the base salary range for this position is $ – $115,000. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
• Medical, Dental, Vision
• Life Insurance
• 401(k)
• Paid Time Off

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 ().