Description
DESCRIPTION
The Clinical & Commercial Cleaning Program consultant will assist in characterizing the effectiveness of cleaning processes on the variety of soils encountered in manufacturing processes, develop new cleaning processes as needed, and set acceptance criteria. The required work involves execution of these studies in alignment with site plans and procedures. The scope of work includes execution of laboratory studies in a Good Manufacturing Practices (GMP) support environment.
The execution of these studies includes: drafting study plans and protocols in accordance with defined proprietary site strategies, performing laboratory studies, documenting execution for studies in notebooks to GMP standards, engineering studies in GMP environments, analysis of study results, drafting study summary reports, and collaborating with staff on review and approval of summary reports. Once the work has been completed for each project, a report must be written that summarizes the data and closes out that particular project. The report will consist of presenting the data, conducting calculations, and writing discussions on what the results have determined.
Qualifications
- University level education in engineering, biology, or related sciences (M.S. +2yrs or BS +6yrs experience)
- Technical knowledge/understanding of biotechnology manufacturing process equipment
- Strong technical writing skills and experience in experimental design
- Recent experience in the use of laboratory instrumentation and equipment, such as: gel electrophoresis; spectrophotometer, laboratory pipettors; conductivity & pH instruments, etc
- Experience with standard desk top software (ie Word & Excel)
- Experience with laboratory scale cleaning evaluations
- Experience with full scale cleaning equipment (COP washers, Cleaning skids, etc)
SKILLS
MS Excel, MS Outlook, MS Word, Good Manufacturing Practices (GMP), Manufacturing
Synectics is an Equal Opportunity Employer.