The Computer System Validation (CSV) Engineering Support Tech will support cross-functional teams by assisting in drafting and executing validation protocols for computer systems and process control systems. This role also includes supporting ancillary departments such as CAPEX with project management tasks.
Essential Functions:
· Assist in generating and obtaining approvals for validation deliverables, including Validation Plans, Risk Assessments, and Final Reports in compliance with regulatory requirements.
· Support cross-functional teams by planning and organizing validation activities.
· Collaborate with Sr. Engineers and CSV Manager on protocol execution and data analysis.
· Review and update SOPs and related documentation.
· Support project management tasks in CAPEX and other ancillary departments.
· Perform other duties as assigned.
Required Skills & Abilities:
· High School diploma with completion of courses in engineering.
· Strong communication skills, both written and oral.
· Proficient with Microsoft Office products.
· Ability to work in a fast-paced environment and with minimal supervision.
Working Conditions & Physical Requirements:
· Experience prolonged sitting and standing.
· Ability to lift and move items up to 50 pounds.
· Support company manufacturing activities as needed.
Minimum Qualifications:
· High School Diploma
Preferred Qualifications:
· Course of study preferred at bachelor’s level in electrical, mechanical, chemical Engineering or equivalent.
· Interest in biotechnology or pharmaceutical systems.
· Willingness to learn and adapt in a dynamic work environment.
· Basic knowledge of engineering principles and computer system validation.
· Previous internship experience in a biotechnology company or related is a plus.
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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