We are hiring a Project Engineer. The Project Engineer will be responsible for the execution of strategic CAPEX and other related engineering projects to improve efficiency & quality of product while reducing cost and complexity.

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.

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
• 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.

Salary and Benefits:

• $97,000 to $155,250 annually depending on experience.
• Medical, Dental, Vision
• Life Insurance
• 401k
• Paid Time Off

Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).

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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