Senior Validations Engineer
Location: Santa Ana
Posted on: June 23, 2025
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Job Description:
At FUJIFILM Irvine Scientific, 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
world’s 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 you’re ready to make an impact, your future belongs
with us at FUJIFILM Irvine Scientific. 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. Responsibilities • Develop and execute
validation protocols associated with new products, equipment,
systems, and processes used in the FUJIFILM Irvine Scientific
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
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 $103,093- $134,204. 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
Keywords: , Oceanside , Senior Validations Engineer, Science, Research & Development , Santa Ana, California
