Fujifilm Manufacturing USA, Inc

Validations Engineer

Fujifilm Manufacturing USA, Inc • $106K — $115K *
Santa Ana, CA 92704In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BS in Bioengineering, Chemical Engineering, or equivalent required.
  • Minimum 2 years' experience in equipment/process/facility qualifications/validations in regulated industries.
  • Experience in Process Engineering and Manufacturing Engineering is a plus.
  • Knowledge of study design methodologies, especially DOE.
  • Familiarity with validation types such as process and computer system validation.
  • Understanding of FDA/cGMP/QSR guidelines pertinent to validation practices.
  • Proficient English communication skills, both oral and written.

Responsibilities

  • Develop and execute validation protocols for new products and processes.
  • Support qualification/validation execution, including sample collection and data completion.
  • Compile and analyze validation data, and prepare improvement reports.
  • Notify management of protocol deviations and support root cause analysis.
  • Investigate deviations and contribute to problem-solving efforts.
  • Coordinate protocol scheduling with various departments and personnel.
  • Support creation and review of SOPs and train staff as needed.

Benefits

  • Medical, Dental, Vision coverage.
  • Life Insurance provided.
  • 401k plan available.
  • Generous Paid Time Off policy.
Full Job Description
Position Overview

Position 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.

Job Description

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 $ 106,185.25 - $115,000. 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

About Fujifilm Manufacturing USA, Inc

Fujifilm Manufacturing USA, Inc is a subsidiary of Fujifilm Holdings Corporation, a Japanese multinational conglomerate that specializes in imaging and photography. Fujifilm Manufacturing USA, Inc is responsible for the manufacturing of photographic paper, film, and other imaging products in the United States. The company was established in 1988 and has its headquarters in Valhalla, New York. Fujifilm Manufacturing USA, Inc operates as a subsidiary of Fujifilm North America Corporation.
Learn more about Fujifilm Manufacturing USA, Inc
Size
72,332 employees
Industry
Manufacturing & Automotive
NASDAQ
FUJIF
* Ladders Estimates

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