Sr. Engineer, MS&T
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 Manufacturing Engineer position reports to a Principal Engineer or the leader of the Manufacturing Development Department at the Emergent Bayview Manufacturing Facility. The position is responsible for leading process and technology transfer of one or more processes into GMP facility. Conducts, plans, and leads tech transfer and GMP documentation. Represents Manufacturing Development/company at internal and external meetings. This includes but is not limited to creating process budgets, managing internal and external resources, participating in project team meetings, reporting project schedule status, and providing in-suite support for EMOB GMP manufacturing campaigns.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Lead one or more tech transfer projects
• Conduct, plan, and lead tech transfer of one or more processes into manufacturing
• Responsible for coordination of technical activities on assigned projects
• Evaluate incoming processes for operability and develop risk assessment plans
• Work with external groups to support tech transfer activities
• Author and review technology transfer and manufacturing documentation including plans and reports
• Develop Unit Operation and Batch Record Material Usage Requirements for SAP system
• Author CMC Sections with assistance from Principal Engineer and/or Director
• Compare manufacturing batches and evaluate process performance
• Independently perform review of process control parameters and testing protocols
• Develop experiments to allow evaluation of Key and Critical Process Parameters
• Provide technical support to manufacturing in production suite as needed
• Assist with implementation of Unit Operations in Manufacturing Suite
• Contribute to and review process deviation risk assessment and CAPA reports
• Author technical sections of project proposals including evaluation of CapEx requirements and costing
• Determine equipment needs and CapEx for projects
• Coordinate the efforts of support groups and external resources such as vendors, consultants, and contractors
• Assist site validation with process and equipment performance qualification
• Represent EBS to external customers at conferences and/or organizations
• Lead by example through strong work ethics
• All responsibilities of a Manufacturing Development Engineer
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
• Bachelor’s Degree in an engineering discipline or equivalent with 12+ years of process experience, Master’s degree with 6+ years process experience, or PhD with 4+ years process experience
• Process technology transfer experience in two or more of the following:
- Downstream or upstream GMP manufacturing experience
- Viral or non-viral process experience
- Microbial or mammalian process experience
• Experience with Receiving and Evaluating Technology Transfer Data, Development of Bills of Materials, and Evaluation of GMP Manufacturing Suitability
• Experience as a Project Lead
• Knowledge of cGMPs and experience working in a GMP biotechnology or pharmaceutical manufacturing setting
• Detailed knowledge of facilities, systems, and infrastructure within a regulated industry setting
• Experience with SAP or Equivalent ERP system
• Experience with Facility Design/Expansion
• Experience with Design of Experiments to support Process Validation
• Ability to operate process and analytical equipment and other instruments
• Experience with authoring protocols and reports to facilitate technology transfer to a manufacturing environment
• Familiarity with analytical methodologies for determining protein structure, concentration, and purity
• Experience with writing SOPs, batch records, production protocols, deviation assessments, and technical reports for GMPs
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.