Manufacturing Support Associate 2

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki

 

Join us 

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

 

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

 

About This Role

The Manufacturing Support Associate 2 provides reliable support to the Drug Product Manufacturing operation during the establishment of the facility and processes. This position supports the creation of standard operating procedures, processes, trainings and documentation along with supporting tech transfer, batch planning, documentation updates and coordination of non‐batch activities including changeover, PMs, deviation management and audit preparation.

External US

What You’ll Do 

• During the project phase, support operational readiness initiatives as well as site commissioning and qualification
• Owns and drives drug product operational readiness document plan, contribute to preparation of standard operating processes (SOPs) and documentation packages as defined by the project plan
• Participates in operational readiness project meetings and support factory acceptance testing (FAT) and site acceptance testing (SAT), as required
• Actively participates in establishment of batch handling processes for Drug product manufacturing
• Executes and drives minor projects and initiate change management request including optimization projects
• Leads and guides shop floor deviation investigation from initiation through closure
• Provides training and mentor junior level team members
• Perform other duties as assigned

 

Who You Are 

You will perform manufacturing support activities related to drug product and finished goods to ensure compliant and reliable production. You will support change management records, investigations, corrective and preventive actions, documentation updates and more.

 

Basic Requirements 

• High School Diploma or GED with 6 years direct experience OR
• Associate’s degree with 4 years of direct experience OR  
• Bachelor’s degree with 2 years of direct experience OR  
• Equivalent Military training or experience
• Strong verbal and written communication skills
• Knowledge from operational experience with formulation, filling and visual inspection processes and production equipment. 
• Knowledge of cGMP from a pharmaceutical production
• Ability to adapt in a fast‐paced environment, pivot and adjust plans accordingly
• Ability to think critically and have superior problem‐solving skills.
• Experience with IT systems (Office and ERP systems)

 

Preferred Requirements 

• Associate degree in life sciences 
• BA/BS, in life sciences or engineering
• Prior cGMP experience from a pharmaceutical production environment
• Preferable operational experience with formulation, filling and visual inspection processes and production equipment.

 

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Will work in environment which may necessitate respiratory protection X No Yes
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes
• Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes
• Ability to discern audible cues. No X Yes
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