Employment 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.
Position Summary
The Senior Process Engineer will be a member of the Process Development and Production team. This position will be focused on the support of clinical production in a cGMP facility, as well as, leading/supporting projects focused on equipment design, specification, installation, commissioning, qualification, and process scale-up. This includes but is not limited to creating process budgets and managing external resources.
Essential Functions
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Lead the design, implementation and sustainability of manufacturing processes from feasibility through scale-up and commercial manufacturing
Ensure robust systems using accepted GMP design controls
Working with cross-functional teams to determine system requirements and specifications
Create, contribute to, and review process deviation risk assessments and CAPA reports
Evaluate incoming processes for operability and develop risk assessment plans
Process development, scale-up, technology transfer and equipment/process validation activities
Author, review, and approve all SOPs and technical documents throughout the equipment/system lifecycle from commissioning and qualification through decommissioning and retirement
Responsible for coordination of technical activities on assigned projects
Maintain compliance with applicable cGMP regulations, vendor guidelines, engineering principles, and documentation
Minimum Education, Experience and Skills
Bachelor’s Degree in an engineering discipline or equivalent with 8 years of process experience in the biotech or pharmaceutical industry; PE license preferred
Expert knowledge in upstream and downstream bioprocessing
Excellent written and interpersonal skills
Strong data analysis, troubleshooting and problem-solving skills
Strong understanding of equipment qualification, validation, scale up and tech transfer
Manage relevant engineering activities and prioritize work to ensure site and project timelines are met
Expert knowledge in practice of researching, engineering, and design, as well as evaluating alternatives
Expert knowledge of engineering principles, standards, techniques, policies, and processes.
Experience with Facility Design/Expansion
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
Ability to read and understand drawings, schematics, tolerances, and limits
Preferred:
Fill/finish knowledge
Experience in Design of Experiments (DOE) and use of statistical analysis software (JMP)
Working knowledge of design (Solidworks) and fabrication of parts and assemblies
Understanding of 21 CFR parts 11, 210 and 211 a plus
Working within a controlled production environment
Working with potentially infectious materials
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.
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 Privacy Policy .
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.