BioProcess Associate (2nd Shift)
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
I. JOB SUMMARY
The Bioprocess Associate position reports to Supervisor Manufacturing. Prior experience in GMP manufacturing, operation of GMP process equipment and aseptic technique are preferred but not required. This role is responsible for filling of parenteral pharmaceuticals in accordance with cGMP regulations, setup and operation of equipment and processes associated with sterile filling processes, and 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 Supervisor 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 including recording entries in batch records or equipment logbooks.
• Train in setup, assembly, and operation all equipment necessary for the daily manufacturing of products, especially related to aseptic operations in the sterile core or sterile isolator, in accordance with current industry, client and EBSI standards.
• Assist the Validation and Maintenance staff with the operation and execution of engineering projects.
• Perform housekeeping, plant upkeep, and sanitization activities throughout production area as required.
• Obtain proper Gowning Qualifications necessary for routine aseptic operations, including filling operations and cleaning.
• Assist with the preparation of materials needed for sterile filling.
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.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• BA/BS in any field
• Or High School/AA with at least one year experience in a GMP environment
• Ability to work independently with minimal guidance and as part of a team
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.
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.