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BioProcess Associate

Emergent BioSolutions
Baltimore, MD Full Time
POSTED ON 7/24/2024 CLOSED ON 8/17/2024

What are the responsibilities and job description for the BioProcess Associate position at Emergent BioSolutions?

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.

I. Job Summary

Perform filling of parenteral pharmaceuticals in accordance with cGMP regulations. Responsible for setup and operation of equipment and processes associated with sterile filling processes. Responsible for daily cleaning and sanitization activities throughout the production area.

Ii. Essential Functions

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

  • Work under general supervision of more experienced Technicians or Manufacturing Supervisors to produce parenteral drugs.
  • Comply with cGMP regulations, adhere to EBSI policies, and adhere to EBSI SOP and Batch Record directions.
  • Complete all necessary documentation in a manner that complies with Good Documentation Practices as tasks are performed.
  • Independently set up, assemble, and operate all equipment necessary for the daily manufacturing of products, especially related to aseptic operations in the sterile core,

in accordance with current industry, client, and EBSI standards.

  • Effectively troubleshoot equipment during operation to ensure effective and efficient operations while maintaining high quality and service to the client.
  • Assist the Validation and Maintenance staff with the operation and execution of engineering projects.
  • Conduct training sessions for less experienced Technicians to ensure a high level of effectiveness and quality is met during production operations.
  • Perform housekeeping, plant upkeep, and sanitization activities throughout the production area as required.
  • Prepare clean or sterile equipment as necessary for routine aseptic operations
  • Maintain proper Gowning Qualifications necessary for routine aseptic operations, including filling operations, cleaning of ISO 5/6 areas, and loading/unloading Terminal Sterilization autoclaves and Lyophilizers

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 management's right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

Iii. Minimum Education, Experience, And Skills

  • BA/BS in any field
  • Or High School/AA with at least 3 years of experience in a GMP environment
  • Ability to work independently with minimal guidance and as part of a team
  • Experience using computer applications, including data statistical, word processing, spreadsheet, and presentation software.

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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.
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