Manufacturing Support Associate 1, DP

Position Overview

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 Description

What You'll Do

During Project Phase:

• Leads operational readiness initiatives as well as site commissioning and qualification efforts

In Operations:

• Supports and participates in troubleshooting in the respective process area, as assigned
• Performs documentation updates to support reliable production
• Creation of non‐batch activities and creation of associated documentation for tech transfer, changeover, preventive maintenance plans (PMs), and column packing
• Supports change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities to support manufacturing
• Supports inspections and audits by providing requested manufacturing documents, as needed
• Performs other duties as assigned

Basic Requirements

• High School Diploma/GED and 4 years related experience OR
• Associate degree in life sciences with 2 years of direct experience OR
• BA/BS in life sciences with no experience OR
• Equivalent Military training/experience

Preferred Requirements

• Previous cGMP manufacturing operations experience
• Understanding of change management, investigations, CAPAs and CIs
• BioWorks or BTEC Capstone cGMP coursework preferred

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Ability to discern audible cues
• Ability to stand for prolonged periods of time - Up to 60 minutes
• Ability to sit for prolonged periods of time - Up to 60 minutes
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
• Ability 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.