Participate in design and construction meetings. Track action items and deliverables for various activities. Coordinate small capital and non capital projects at the Gaithersburg site. Identify improvement opportunities and presents options and project plans to the VP. Maintain and organize project related documentation; schedules, RFIs, submittals, change control, etc. R

Draft and execute IQ, OQ, PQ validation protocols (Equipment, Utilities, Computerized Systems, EMPQ, Aseptic Process Qualifications, etc.). Conduct risk assessment, create FMEAs and other documents to justify the validation approach being taken. Organize and coordinate qualification activities for new equipment (i.e. onboarding of new laboratory and manufacturing equipmen

Manage day to day efforts and coordinate calendar of assigned team to ensure adequate pre and post sales support for designated products. Assist in setting of priorities where needed, based on business drivers. Learn the MACSima training process and support process to ensure the success of select priority customers with installation training and follow up support Work wit

Analyze and document requirements in details and design and document the best fit system or modify an existing system. Develop detailed business requirements and functional specification documents. Create and deliver training materials and procedures and work instructions to group users. Develop setups, EDI maps, interface when applicable and document. Test application an

Conduct onsite service activities at customer locations throughout a multi state geographic region. Services performed include repairs, installations, preventive maintenance, and various levels of validation services on complex scientific instrumentation. Work independently without direct supervision or ready access to technical support in all cases. Plan, prioritize and