Manufacturing Associate - Limited Term

Emergent Biosolutions•Lansing, MI

1d•$39,000 - $47,100•Onsite

About The Position

This Manufacturing Associate role is a limited term position scheduled to end in September 2027. 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.

Requirements

HS Diploma
1-2 years’ experience working in a CGMP environment
Knowledge of CGMP and CFR requirements preferred but not required
Personal Competencies: Self-awareness, Integrity, Team Player, Creative, and Culturally aware

Nice To Haves

Knowledge of CGMP and CFR requirements

Responsibilities

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 StandardOperating 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
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
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
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
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.
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 culture through manual addition of 2N NaOH aliquots to a defined pH range
Install sterilizing grade filters, perform integrity testing and execute sterilization of filter skid
Monitor culture turbidity to verify growth to required process parameters and filter culture from 1320L fermenter to Harvest Tank
Add ALOH to Harvest tank.
Draw samples and submit them through LIMS.
Clean and sterilize Harvest Tanks
Clean and sterilize centrifuge as well as run the centrifugation processes
Dispense and sterilize ALOH
working collaboratively with others, communicating, and managing conflict effectively
cultivating innovation and nimble learning
ensuring accountability, and making good and timely decisions
demonstrating courage and focusing on customers
gaining the confidence and trust of others through honesty, integrity and authenticity
making sense of complex, high quantity, and sometimes contradictory information to effectively solve problem
plan and prioritize work to meet commitments aligned with organizational goals
creating a climate where people are motivated to do their best to help the organization achieve its objectives