Production Engineer

Position Description

We are hiring a Production Engineer. The Production Engineer bridges the gap between engineering and manufacturing. They 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.

At FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences), we turn curiosity into breakthroughs that advance the field of life sciences. By offering a comprehensive portfolio of products and services in cell culture media, discovery research reagents, recombinant growth factors and proteins, fine chemicals, and critical assay materials, we partner with the brightest minds in biotech and pharma to tackle the world's biggest health challenges.

Imagine being part of a team that enables life-changing discoveries like new vaccines, therapies, and advancements in regenerative medicine. Our culture fosters curiosity, collaboration, and innovation, and we pride ourselves on delivering unparalleled quality and service to our partners. If you're ready to make an impact, your future belongs with us at FUJIFILM Irvine Scientific (dba FUJIFILM Biosciences).

Our headquarters in Santa Ana, California, is surrounded by world-class schools, lush parks, and scenic beaches like Laguna and Huntington, making it an ideal place to live, work, and explore. With additional campuses across the US, Europe, China, and Japan, we offer opportunities to make a difference worldwide.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:

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 $88,452 - $115,293 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

• LI-onsite
  

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ).