Assistant Manufacturing Associate

Preparedness today, safer tomorrow.

Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

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 Bio Solutions 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 Assistant 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 (Delta

V)

* Prepare and dispense intermediate materials.

Behavior/Cultural Responsibilities

* Standing Shoulder to Shoulder (no matter what):

* working collaboratively with others, communicating, and managing conflict effectively

* Break Through Thinking:

* cultivating innovation and nimble learning

* Own It Always:

* ensuring accountability, and making good and timely decisions

* Compete Where It Counts:

* demonstrating courage and focusing on customers

* Integrity and Instills Trust:

* gaining the confidence and trust of others through honesty, integrity and authenticity

* Manages Complexity:

* making sense of complex, high quantity, and sometimes contradictory information to effectively solve problem

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