The Process Scientist/Engineer I represents the technical operations department before FDBU customers, regulatory agencies and management. This individual will manage the new client process and ensure project objectives are completed. The Process Scientist/Engineer will also contribute to the technology transfer of multiple projects at various project life-cycle stages (clinical material to commercial supply). Additionally, this individual must possess strong process understanding to implement and execute process risk review and process/cleaning qualification and validation activities.
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- May support technical transfer of client project in and to manufacturing as applicable
- Summarizes and report data
- Interacts with supervisor and reports results and interpretation of experiments, project deliverables, and process readiness.
- Supports capital projects by providing technical expertise
- Supports new project site-fit assessments as needed
- Assists in developing SOPs and engineering documents
- Familiar with relevant literature
- Independent use and application of, computer systems and software for data acquisition and analysis
- Capable of using basic computer systems and software to perform basic data analysis
- Basic math and software skills (excel data plotting, proficient with MS Word for memos and updates)
- Acquire understanding of GMPs, safety, SOP, discipline practices and terminology
- Acquire understanding of basic production and production troubleshooting
- Work under close to moderate supervision with limited latitude for independent judgment
Demonstrates a practical understanding of own engineering discipline and applies knowledge in support of product development and technical transfer. Provides solutions to a variety of problems of moderate scope and complexity. Consult with senior peers on non-complex process engineering projects to learn through experienceMaintains accurate records of ongoing projects in adherence with documentation standards.May prepare summaries of data for technical reports (memos, development reports)Writes SOPs and other cGMP documentsCollaborates and communicates within and across the work group as needed. May present at departmental meetings to keep managers and team members apprised of the activities on project.Communication across work teams 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 listeningReceptive to direction from colleagues
- BS. degree or equivalent; or four to ten years related experience and/or training; or equivalent combination of education and experience
- Independent use and application of, computer systems and software for data acquisition and analysis Capable of using basic computer systems and software to perform basic data analysisBasic math and software skills (excel data plotting, proficient with MS Word for memos and updates)Acquire understanding of GMPs, safety, SOP, discipline practices and terminologyAble to acquire an understanding of basic production and production troubleshooting
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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