Intern - Documentation Writer

Posted Feb 22, 2019
Project ID: SHPGJP00004194
Lexington , MA
3 months
(May 21, 2019 - Aug 18, 2019)
40 hrs/week
Payrate range
Intern Project The interns will be tasked with examining the current manufacturing processes and compare them to processes as described in the applicable SOPs and Batch Records. The interns will then develop solutions to harmonize the written process with floor processes to create best practices in a cGMP environment. This is an opportunity to learn cell culture operations in a large scale environment. The intern will get hands on exposure to the upstream life cycle and identify gaps in the process. The intern will have opportunities to witness and take part in cell culture sterilization techniques, support mammalian cell culture manufacturing processes, operate various process equipment, learn documentation of daily manufacturing operations in a cGMP environment, work with disposable perfusion bioreactors and chromatography columns. Required Skills Strong technical writing skills preferred. Strong written and verbal communication skills. Demonstrate high-level of professional and business judgment when communicating with cross-functional teams and others at all levels of the organization. Proficiency with Microsoft Office applications, including Word, Excel and Power Point. Problem Solving abilities. Work on projects of routine problems of limited complexity and scope while following established policies and procedures. Identify and analyze opportunities for process improvement. Make certain that documents contain accurate details and instructions corresponding with the activity. Ensure that the information contained in documents correspond with the information of related documentation and that they adhere to all GMP requirements. Technical Skills Ideal candidate will have experience working in a lab or clean room environment and some familiarity with the operation of bioreactors and/or chromatography columns. Other Requirements Ability to gown into clean rooms Preferred area of study and completed years Life Sciences or Engineering Working towards or completion of an undergraduate degree

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