Job Information
Fujifilm Sr Validations Engineer- SaaS in Santa Ana, California
Overview
We are hiring a Sr Validation Engineer. The Sr Validation Engineer will perform validation activities related tosoftware and software as a service (SaaS).
Company Overview
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.
Job Description
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.
Validation exp with SAP highly preferred.
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
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.
*#LI-Hybrid
EEO Information
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.
ADA Information
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).
Job Locations US-CA-Santa Ana
Posted Date 3 weeks ago (12/26/2024 3:04 PM)
Requisition ID 2024-28053
Category Validation
Company (Portal Searching) FUJIFILM Irvine Scientific, Inc.