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, Inc. adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. The companys consultative philosophy and expertise in cell culture and compliance provide customers with unique capabilities and support. For over 50 years, FUJIFILM Irvine Scientific, Inc. 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 Production Engineer. The Production Engineer will bridge the gap between engineering and manufacturing. They will actively participate in optimizing assigned processes, troubleshoot issues on the production floor, and manage engineering projects impacting production of liquid & powder media, diagnostic kits, and biological products manufactured by Irvine Scientific.

Responsibilities

• Collaborate with team members to improve processes related to health, safety and environment.
• Analyze and identify areas for improvement in current manufacturing processes. Implement solutions to enhance efficiency, quality, and yield.
• Actively participate in and troubleshoot production activities on the shop floor. Ensure adherence to established procedures and safety protocols.
• Collaborate with manufacturing teams to integrate new products seamlessly. Identify and optimize processes for successful production launches.
• Lead investigations into deviations and non-conformances. Develop and implement corrective and preventative actions to minimize future occurrences.
• Utilize process and utility system knowledge to improve equipment functionality and overall manufacturing efficiency.
• Support the implementation of new production equipment. Design, procurement, cGMP documentation, commissioning, and qualification activities.
• Propose, write, review, and revise departmental Standard Operating Procedures (SOPs) to ensure clarity, consistency, and quality in production practices.
• Work cross functionally to maintain and improve the accuracy of Bill of Materials (BOM) and Electronic Batch Records (EBRs) for existing products. Provide technical feedback and ensure completeness during the setup of new parts and processes.
• Provide technical assessment and ensure any impact to manufacturing is captured during management of change process.

Required Skills/Education

• Bachelor of Science in Chemical Engineering, or similar Scientific/Engineering background.
• 5-7 years of experience in manufacturing engineering, process engineering, project engineering, or similar role in a cGMP environment.
• Understanding of Good Manufacturing Practice (GMP) regulations and guidelines set forth by regulatory agencies, such as the FDA, for the manufacturing of life science products.
• Prior experience working in a GMP manufacturing environment with a variety of bioprocessing equipment is highly preferred.
• Excellent communication and customer-oriented skills with ability to work in a matrix / cross-functional organization.
• Knowledge and experience working within a quality management system, including investigation resolution, Corrective and Preventative Action (CAPA) implementation, and change control procedures.
• Familiarity with and ability to apply concepts of Lean Manufacturing for waste reduction and process optimization, and Six Sigma for quality improvement methodologies.
• Prior experience working in the life sciences industry is a plus.
• Ability to speak, read, and write in English.
• Good oral and written communication skills

Salary and Benefits:

• For California, the base salary range for this position is $83,300 to $133,400 annually. 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

EEO/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.

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.

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