Assistant Manufacturing Associate - Limited Term Hire

Location: 

Lansing, MI, US, 48906


 

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 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 (DeltaV)
•    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

•    Plans and Aligns:

  • plan and prioritize work to meet commitments aligned with organizational goals

•    Drives Engagement:

  • 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 
•    0–1-year 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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Lead with Integrity
    • We gain trust and confidence through ethics, quality, and compliance excellence
  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Lansing