Validations Engineer

At FUJIFILM Biosciences we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media discovery research reagents recombinant growth factors and proteins fine chemicals and critical assay materials we partner with the brightest minds in biotech and pharma to tackle the worlds biggest health challenges.

Imagine being part of a team that enables life-changing discoveries like new vaccines therapies and advancements in regenerative medicine. Our culture fosters curiosity collaboration and innovation and we pride ourselves on delivering unparalleled quality and service to our partners. If youre ready to make an impact your future belongs with us at FUJIFILM Biosciences.

Our headquarters in Santa Ana California is surrounded by world-class schools lush parks and scenic beaches like Laguna and Huntington making it an ideal place to live work and explore. With additional campuses across the US Europe China and Japan we offer opportunities to make a difference worldwide.

Fujifilm is globally headquartered in Tokyo with over 70000 employees across four key business segments of healthcare electronics business innovation and imaging. We are guided and united by our Group Purpose of giving our world more smiles. Visit: Description

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

Responsibilities:

• 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 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.
• 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 Validation Manager.

Required Skills/Education:

• 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.

Salary and Benefits:

• For California the base salary range for this position is $ 106185.25 - $115000. 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

*#LI-onsite

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 pre-employment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department ().