Manufacturing Associate

 

Emergent BioSolutions is committed to assisting employees achieve their professional goals.  Internal job postings are one of the tools available to employees at Emergent BioSolutions to assist in their  career management.  This enables current employees who have remained in their current position for a minimum of one year to apply for an open position.

I.    JOB SUMMARY 

Execute tasks per CGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing training program. Actively incorporate the Shared Values set out by Emergent BioSolutions while performing day to day activities.

 

II.    ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

 

General

• Complete training and demonstrate competency on Manufacturing Associate qualification blocks in accordance with the training progression pathway
• Execute and document procedural steps in compliance with CGMP standards, clean room behavior and Standard Operating Procedures
• Comply with all applicable rules and regulations of Emergent and the Pharmaceutical / Biotech industry. This includes FDA regulations such as CGMP, GDP, EH&S regulations, and company regulations such as the employee handbook
• Maintain state of facility environmental control including: preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly and annual cleaning of manufacturing areas per Standard Operating Procedures  
• Review all documentation for accuracy and completeness of process signature steps as each step is completed. Perform “real time” review of all documentation (BPRs, forms, logs, etc.) in the area throughout the shift
• Stock gowning and consumable supplies in the controlled areas maintaining Kanban inventory control of manufacturing materials

 

Lean Concepts

• Follow standard work guidelines
• Collaborate with applicable Integrated Process Teams to participate in continuous improvement and learn new Lean concepts
• Actively participate in Kanban and 6S programs

 

Inspection and Packaging

• Successfully complete inspector qualification requirements to identify, classify and cull product defects, including those defects which could impact patient safety (inspector qualification)
• Independently operate labeling equipment with minimal supervision (Qualification)
• Apply traceability and expiration information to secondary packaging components such as cartons and cases. Confirm suitability of secondary packaging components during printing processes through 100% inspection (carton printing, case creation)
• Package product in secondary and final packaging components while performing 100% reconciliation of product rejects (Packaging)
• Complete ambient tracking documentation
• Execute material issuance and confirmation of process steps using specific SAP modules

 

Building 55 Operations – Prep

• Execute material issuance and confirmation of process steps using specific SAP modules
• Precisely weigh and hydrate media components
• Load, run and unload parts washer and sterilization/decontamination using specific validated load configurations per Standard Operating Procedures
• Assemble clean process glassware configurations and portable tanks utilizing sanitary connections, quick connects and stainless-steel ancillary parts
• Perform Cleaning (COP/CIP) and Sterilizing (SOP/SIP) of production vessels through interface with automated control system (DeltaV)
• Prepare and dispense intermediate materials

 

Building 55 Operations – Upstream 

• Execute detailed manual and high impact process tasks requiring extensive documentation and interface with automated controls.   Process operation involves manual orientation of valve configurations and monitoring/adjustment of vessel pressures during execution to maintain the sterile envelope and create differentials to facilitate transfers.  Description of specific requirements include:
• Clean and Sterilize 10L, 120L and 1320L fermenters to defined and validated parameters through interface with automated control system 
• Sterilize media filters and sterile filter seed, intermediate and production media 
• Inoculate 10L fermenter through addition of inoculum via peristaltic pump  
• Monitor culture turbidity to verify growth to required process parameters and transfer culture from the 10L to 120L and the 120L to 1320L fermenters upon verification of achievement of these parameters
• Adjust pH of cu