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, and regenerative medicine, assisted reproductive technology and cytogenetics, and industrial cell culture for the large-scale production of biotherapeutics and vaccines. FUJIFILM Irvine Scientific adheres to both ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company's consultative philosophy combined with expertise in cell culture and compliance provides customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific 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 for a Quality & Technical Engineer. This role is a critical position to the Quality Systems and Regulatory team. The Quality & Technical Engineer provides statistical information for quality improvement by identifying and implementing efficiencies, such as new or improvements for assay method identification, development and transfers to GMP, Stability Program, Risk Assessments of the various product and processes changes with focus on leading and driving continuous improvement with the objective to build capability within the organization to eliminate risk and improve efficiencies.
External US Responsibilities:
- Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes
- Establishes statistical confidence by identifying sample size and acceptable error; determining levels of confidence
- Establishes statistical reliability by using mean time before failure, 3-parameter distribution, reliability modeling, and reliability demonstration tests
- Develops experiments by applying full and fractional factorial techniques as well as experience in Cell Culture company
- Develops sampling plans by applying attribute, variable, and sequential sampling methods
- Maintains statistical process controls by applying demerit/unit, zone charting, x2 charts for distributions and individual-medial/range for multi-stream processes
- Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests
- Prepares reports by collecting, analyzing, and summarizing data; making recommendations
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies; maintaining American society of quality control certified quality engineer qualification
- Provides support with the sister companies and affiliates during their process and product transfer, such as IST
- Contributes to team effort by accomplishing related results as needed
- BS/BA in Microbiology, Biology or Chemistry; advanced study in Microbiology is highly desirable
- 5 or more years of biological or microbiological laboratory experience
- Good skills in tissue culture, biochemical, and microbiological testing methodologies
- Ability to analyze information and report research findings
- Strong technical understanding
- Promoting Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods and Procedures, Supports Innovation, CAD, Quality Engineering, Operations Research
- Detailed understanding of 21 CFR Part 211, 21 CFR Part 820, ISO 13485, Canadian MDR, MDD 93/42 with emphasis on laboratory testing, material specifications, and related areas
FUJIFILM Irvine Scientific is an equal opportunity employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable 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.