The Manufacturing Support Associate 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.
Job DescriptionWhat You’ll Do
During Project Phase:
Leads operational readiness initiatives as well as site commissioning and qualification effortsIn Operations:
Supports and participates in troubleshooting in the respective process area, as assignedPerforms documentation updates to support reliable productionCreation of non‐batch activities and creation of associated documentation for tech transfer, changeover, preventive maintenance plans (PMs), and column packingSupports change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities to support manufacturingSupports inspections and audits by providing requested manufacturing documents, as neededPerforms other duties as assignedBasic Requirements
High School Diploma/GED and 4 years related experience ORAssociate degree in life sciences with 2 years of direct experience ORBA/BS in life sciences with no experience OREquivalent Military training/experiencePreferred Requirements
Previous cGMP manufacturing operations experienceUnderstanding of change management, investigations, CAPAs and CIsBioWorks or BTEC Capstone cGMP coursework preferred
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
Ability to discern audible cuesAbility to stand for prolonged periods of time - Up to 60 MinutesAbility to sit for prolonged periods of time - Up to 60 MinutesAbility to conduct activities using repetitive motions that include wrists, hands and/or fingersAbility to conduct work that includes moving objects up to 10 pounds
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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