Posted in Other 30+ days ago.
Type: Full Time
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.
The Senior Manufacturing Associate is primarily responsible for the production of bulk vaccines in accordance with cGMP documentation to meet the production schedule and goals of the site as well as cleaning of the GMP areas. Operations include CIP, SIP, operation of autoclaves and parts washer, production activities and cleaning of the facility. Responsible for operating in a safe and GMP compliant manner, to ensure production goals are met.
- Executes production processes described in the job summary for bulk vaccine manufacturing in accordance with cGMP documentation in the manufacturing area. Ability to operate manual, semi-automated, and automated equipment in support of routine production under supervision.
- Operation of autoclave, parts washer, filter integrity tester, manifold preparation, and production activities as needed.
- Maintains equipment in area as required per procedure and observes cleaning techniques and performs cleaning activities in the area as directed.
- Ensures training requirements are kept up to date in operations being performed.
- Maintains a cGMP ready state of production facility. Documents work performed in logbooks and batch records in accordance with good documentation practice procedures.
- Identifies and initiates process deviations, troubleshoots issues immediately, and assists with investigation and potential corrective actions to quality incidents.
- May perform as SME for cleaning the GMP areas. Interacts with the contract cleaning team to complete cleaning. Will be qualified on cleaning processes and techniques.
- The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
- A minimum of 2-4 years of related experience in a biopharmaceutical/ biotech production environment and a Bachelor's Degree required or a minimum of 3-5 years of related experience in a biopharmaceutical/ biotech and an Associate's Degree or High School Diploma.
- Must have a technical understanding of operations carried out within a cGMP manufacturing area and understanding of MFG operations and cleaning techniques. Must be quality focused with knowledge and understanding of cGMP quality systems and their application to manufacturing operations.
- Ability to maintain and operate laboratory equipment such as pH meters, conductivity meter, filter integrity tester, scales, pumps, and autoclave.
- Excellent written and verbal communication skills.
- Must be a team player and able to work cross-functionally in a matrixed environment.
Physical/Mental Demands and Work Environment Characteristics
- There are physicalmental 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 does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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 .
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.