Quality & Technical Engineer

Overview

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, 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 ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The company's consultative philosophy and expertise in cell culture and compliance provide 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 a Quality & Technical Engineer. This role is this role is a critical position to the Quality Systems and Regulatory team. 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:

• Assesses, investigates, and verifies information related to non-conformances and their actions. Participates and leads MRB meetings and related activities
• Writes and reviews quality plans
• Helps and drives continuous improvement within the organization. Especially in relation to non-conformance, CAPA, audit observations, complaints, quality index, and other quality datasets.
• Analyzes data by completing hypothesis, normal distribution, and process capability analysis tests. Provides input into process, assay, test, and equipment variation and improvement.
• 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.
• Contributes to team effort by accomplishing related results as needed

Experience/ Education:

• 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.
• Ability to speak, write, and read English well.
• Good oral and written communication skills.

PHYSICAL DEMANDS described here are representative of those that must met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to per essential functions.

• Duties require the use of hand dexterity to manipulate fluids and powders to perform applicable tests in clean room environments, laminar flow hoods, and laboratory benches.
• The employee is frequently required to stand. The employee is occasionally required to walk, sit, use hands to handle, feel or reach with hands and arms; climb or balance; and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision, and depth perception.

WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• The noise level in the work environment is that of a busy laboratory office with telephones, computers and printers operating and with frequent people interruptions.
• Required to perform duties in a laboratory environment with required dress and hygiene.

For California, the salary range for this position is $97,000 to $155,000 annually. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).



EEO/COVID/AGENCY NOTES



Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.



In the event that COVID-19 vaccine mandates issued by the federal government, or by state or local government become effective and enforceable, the Company will require that the successful candidate hired for positions covered under relevant government vaccine mandate(s) be fully vaccinated against COVID-19, absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption. For all positions, the Company encourages vaccination against COVID-19 and may require that the successful candidate hired be willing to test for the COVID-19 virus periodically and wear a face covering indoors absent being granted an accommodation due to medical or sincerely held religious belief or other legally required exemption.

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.