Assoc Engineer II, Manufacturing Technology
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 Associate Engineer II will provide hands on execution and support for the development/scale-up/process improvement activities in the pilot facility located at the Canton, MA site.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
The Associate Engineer II(s) will be responsible for:
• Preparation of solutions and media as needed
• Perform static and dynamic cell culture, virus handling and propagation, cell disruption, clarification microfiltration, media/solution preparation, manifold preparation, autoclaving, parts washing, material inventory, and associated steps for upstream and downstream activities
• Cell culture expansion in static phase using aseptic technique as well as cell bank development activity as required
• Cell culture expansion in dynamic phase using bioreactors
• Virus handling and propagation
• Small scale downstream operations including: cell disruption, clarification, microfiltration, and associated steps as required for purification and concentration activities
• Execute development studies, collect and analyze data, ensure documentation meets good documentation practices
• Process monitoring data entry for cGMP runs
• Collaborating with Engineering, Facilities, Validation, Manufacturing, and vendors for commissioning and qualification of new pilot equipment
• Write and revise development reports based on small scale runs executed
• Write and revise operating procedures, protocols, and other documents as required
• Troubleshoot and support MTech investigations, CAPAs, and change controls as needed
• Support routine operations in the pilot laboratory (solution preparation, material inventory and stocking, equipment monitoring)
• Maintain qualifications for site training requirements and demonstrate quality and safety for all operational activities.
• Developing work practices that result in improved efficiency within the department and company.
• Determining methods and procedures on new moderately complex assignments and implementing them after obtaining necessary stakeholder approvals.
• Demonstrating strong interpersonal skills and time management skills when working within the department as well as with other stakeholder groups.
• Demonstrating technical proficiency, creativity, collaboration with others, and independent thought
• Support Manufacturing Technology quality systems (deviations, CAPAs, and change controls), collect and analyze data, write and revise procedures and protocols, collaborate with other departments on commissioning and qualification activities, use GDP and GLP, and have an interest in further developing operational skills to perform a variety of activities.
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
• BS in Bioengineering, Chemical Engineering, Bioprocessing or Biology or related field and/or a minimum 3-5 years related industrial experience
• Demonstrated knowledge and experience in upstream (cell culture), downstream (purification), and media preparation activities
• Some experience with data entry and data analysis
• Basic skills and fluency in Microsoft Word, Excel, PowerPoint
• Strong interpersonal, time management, laboratory, and computer skills
• Demonstrates success in commitment, accountability, technical proficiency, creativity, and collaboration with others and independent thought.
• Makes decisions exercising judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Ensures cross-functional alignment and communication of issues and strategies.
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.