cGMP Process Consultant

at  Pharmeng Technology Inc

• Participate in start-up of new facility, equipment, and processes in manufacturing.
• Advanced cGMP knowledge a must
• Knowledge of Chromatography and Tangential Flow Filtration a plus but not mandatory
• Responsible for writing, executing, and summarizing efforts to develop equipment process parameters per the site SOPs, user requirements, and product needs.
• Assures professional and quality performance in all activities, meeting times, and cost and cGMP requirements.
• Adaptive and flexible to scheduling of engineering runs.
• Coordinates activities necessary to execute engineering study (lab support, commodities, etc.).
• Responsible for problem diagnosis / root cause(s) determination (automation, mechanical, documentation, training, etc.).
• Assists in documenting changes/updates to manufacturing processes and working with manufacturing, engineering, and validation to implement those changes.
• Coordinate activities with the automation team to resolve automation issues and changes.
• Coordinate activities with maintenance to resolve mechanical issues.
• Additional activities related to equipment Engineering Studies as determined by the team lead.

Please refer the Job description for details