FUJIFILM Holdings America Corporation Looking for Project Engineer at Santa Ana, CA  Full Time

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 looking for a Project Engineer. The Project Engineering will be responsible for the executing of Strategic CAPEX and other related engineering projects to improve efficiency & quality of product while reducing cost & complexity.

Responsibilities

Lead the implementation of assigned engineering projects.
• Develop equipment/system specifications, identify infrastructure requirements and perform feasibility assessments as required for each project.
• Review, markup and ensure project documents such as specifications, submittals, RFIs, test documents, drawings and/or other project specific documents are created and documented accurately.
• Work with outside vendors and contracting firms to bring projects from concept to implementation.
• Providing solutions to technical problems that may arise during the life cycle of projects.
• Support project activities with designers, contractors, and vendors.
• Work with contractors during projects implementation as required.
• Works with quality and validation to ensure proper testing, inspection, validation and release of projects.
• Support equipment IQ/OQ/PQ or any other validation/commissioning startup activity as required.
• Ensure new equipment operates in compliance with required EHS, regulations and codes.
• Develop, write, edit and/or review in collaboration with cross functional team SOPs, P&IDs and other procedures for new equipment and/or systems.
• Able to work with other contractors, manufacturing, validations and quality personnel regarding changes or improvements to the systems.

Required Skills/Education

• Bachelor of Science in engineering, or similar scientific background/experience
• 5 years engineering experience
• Must be able to travel internationally up to 30% of the time
• Knowledge of cGMP, FDA regulations and/or medical device manufacturing experience is required
• Ability to identify engineering problems or opportunities and develop / present feasible solutions
• Demonstrated ability to manage and lead engineering projects related to productivity improvement, cost savings, capacity expansion or new process development
• Project Management
• Experience with scale up tech transfers from R&D to Manufacturing
• Proficient in Word, Excel, PowerPoint, Outlook, Project software
• Must possess excellent technical writing ability
• Ability to speak, read, and write in English
• Good oral and written communication skills

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.