Sr Validations Engineer

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 assistcustomers in advancing healthcare initiatives. Working across discovery research cell and gene therapy reproductive medicineand cytogenetics as well as the largescale production of biotherapeutics and vaccines the Company istrusted by researchers manufacturers and over 50 years FUJIFILM Irvine ScientificsMission has been to empower all who bring medicines and treatments to life with unmatched quality and responsiveness in itsproducts and custom solutions providing customers with the vital resources needed to enrich human lives through innovative accessible therapies. The Companysfacilities 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 centerin China. All sites prioritize strategies that adhere to the FUJIFILM Sustainability ValuePlan 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 FISI facility.
• Lead and support the 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 problemsolving activities to identify root cause(s).
• Coordinates the scheduling of protocol 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 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 crossfunctional 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$103093 $134204. 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 committedto 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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .