BioProcess Associate

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.

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.

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.