Manufacturing Associate

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

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.

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 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

Building 55 Downstream Operations
•    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

Behavior/Cultural Responsibilities

•    Standing Shoulder to Shoulder (no matter what):
o    working collaboratively with others, communicating, and managing conflict effectively
•    Break Through Thinking:
o    cultivating innovation and nimble learning
•    Own It Always:
o    ensuring accountability, and making good and timely decisions
•    Compete Where It Counts:
o    demonstrating courage and focusing on customers
•    Integrity and Instills Trust:
o    gaining the confidence and trust of others through honesty, integrity and authenticity
•    Manages Complexity:
o    making sense of complex, high quantity, and sometimes contradictory information to effectively solve problem
•    Plans and Aligns:
o    plan and prioritize work to meet commitments aligned with organizational goals
•    Drives Engagement:
o    creating a climate where people are motivated to do their best to help the organization achieve its objectives

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

MINIMUM EDUCATION, EXPERIENCE, SKILLS
•    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

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill. 

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.