Project Engineer - Santa Ana, United States - Irvine Scientific
Description
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.
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
Experience/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
For California, the base salary range for this position is $97,000 to $155,250 annually. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).
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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