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FUJIFILM Irvine Scientific ยท 2 days ago
Production Engineer
Santa Ana, CA
Full-time
Onsite
Mid, Senior Level
$83K/yr - $133K/yr
5+ years exp
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Insider Connection @FUJIFILM 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 the management of the change process
Qualification
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Required
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
Ability to speak, read, and write in English
Good oral and written communication skills
Preferred
Prior experience working in the life sciences industry is a plus
Ability to speak, read, and write in English
Benefits
Medical
Dental
Vision
Life Insurance
401k
Paid Time Off
Company
FUJIFILM Irvine Scientific
Develops and manufactures cell culture media for bioproduction, vaccines, cell and gene therapies and assisted reproductive technologies.
501-1,000 employees
H1B Sponsorship
FUJIFILM Irvine Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (2)
2021 (2)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Mayasari Lim
Associate Director, Custom Business
Recent News
European Pharmaceutical Manufacturer
2024-02-10
2023-12-24
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