Sr Validations Engineer at FISI - FUJIFILM Irvine Scientific

FUJIFILM Irvine Scientific, Inc. is a worldwide leader in the innovation and manufacture of cell culture media, reagents, and medical devices for researchers and clinicians. The company provides unrivaled service and quality to scientists working in biopharmaceuticals, cell therapy, regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific, Inc. adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company’s consultative philosophy and expertise in cell culture and compliance provide customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific, Inc. has remained uniquely flexible and focused on media while becoming a strategic global leader in media products and services.  FUJIFILM Irvine Scientific, Inc. is a subsidiary of FUJIFILM Holdings America Corporation, reporting to FUJIFILM Holdings Corporation.

We are hiring a Sr Validation Engineer. The Sr Validation Engineer will perform validation activities related to software and software as a service.

External US

Responsibilities

• Develop and execute validation protocols associated with new products, equipment, systems, and processes used in the FISI 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 software and software as a service 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.
• 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. 
• Ability to speak, read, and write English proficiently.
• Proficient oral and written communication skills.

Salary and Benefits:

• For California, the base salary range for this position is $100,090.00 to $130,295.00 annually. 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

EEO/AGENCY NOTES

Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.

To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.

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