The Process Engineer II will represent the technical operations department before FDBU customers, regulatory agencies and management. This position will manage the new client process and ensure project objectives are completed and will also contribute to the technology transfer of multiple projects at various project life-cycle stages (clinical material to commercial supply). Additionally, the Process Engineer II will implement and execute process risk review, process/cleaning qualification and validation activities.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Support technical transfer of client projects in and to manufacturing as applicable
Summarize and report dataInteracts with supervisor and reports results and interpretation of experiments, project deliverables, and process readiness. Support capital projects by providing technical expertiseSupport new project site-fit assessments as neededConsult with senior peers on non-complex process engineering projects to learn through experienceDemonstrate skill with moderate level of proficiency in administrative workAcquire understanding of GMPs, safety, SOP, discipline practices and terminologyAcquire understanding of production troubleshootingFamiliar with relevant literature Learn and apply basic project management
- Advanced technique and biology, chemistry or biochemistry knowledge
< >Independent use and application of complex instrumentation, computer systems and software for data acquisition and analysis General knowledge of Excel, Word and PowerPoint.Understanding of analytical or process experimental designDemonstrates knowledge of instruments, computer technology, and data analysis required to successfully complete project workMay direct technical work encompassing one aspect of a project.Work under general supervision with latitude for independent judgmentParticipate on project teams to provide scientific and engineering expertiseDemonstrates a practical understanding of own engineering discipline and applies knowledge in support of product development. Understands and applies use of equipment, technology and materials associated with area of expertise and related studies and projects. Works on multiple problems of higher complexity.Implements new methods and processes.Adequately assembles reports and presentations describing scientific information.Familiarity with available new technologies and vendor offeringsAssist in developing SOPs and engineering documentsPrepares summaries of data for technical reports (memos, development reports)Write and review qualification/validation/tech transfer protocolsWrite and review qualification/validation/tech transfer reports or SME content of technical reports (memos, development reports etc)May author reports for internal distribution. Collaborates and communicates across work groups and project teams. Communicates with customers with support from manager or technical lead.Presents at departmental meetings to keep managers and team members apprised of the activities on project.Takes responsibility for the consequences of his/her actionsDemonstrates willingness to share roles with others on the team to advance team's progress as neededPractices attentive and active listeningReviews work to ensure accuracy, completeness, and qualityLooks for opportunities for improving work
- BSc. degree or equivalent and 4+ years of experience, or MS or equivalentAdvanced technique and biology, chemistry or biochemistry knowledgeIndependent use and application of complex instrumentation, computer systems and software for data acquisition and analysis General knowledge of Excel, Word and PowerPoint.Understanding of analytical or process experimental designDemonstrates knowledge of instruments, computer technology, and data analysis required to successfully complete project work.Demonstrates a practical understanding of own engineering discipline and is able to apply knowledge in support of product development.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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