Florida, Lakeland-Winter Haven
: Developing and maintaining project plans, design strategies, validation plans, and other project related activities as applicable.
: Support the selection and validation of equipment.
: Development of materials specifications, product structures, process routing and equipment requirements in accordance with QA/regulatory requirements.
: Support and Development of IQ, OQ, PQ where appropriate
: Support development, ordering and control of process related tooling and materials.
: Communicate, motivate and support development of lower-level technical personnel.
: Actively participate in project team meetings utilizing action plans and project time lines.
: Effectively communicate with external/internal project members, suppliers and service providers
: Effectively initiate design transfer activities into Operations / Commercial status
: Control incoming and outgoing purchase orders and invoices that are relevant for projects.
: Perform and participate in design reviews, risk assessments, quality plans, supplier assessments.
: Cooperate closely with sales and marketing to achieve the best possible customer outcomes.
: Bachelor' s Degree in Sciences or Engineering Preferred
: 5 years of experience in a fast pace manufacturing environment
: 3-5 years' experience as a Projects Team Member
: Excellent written and oral communication skills
: Knowledge of FDA, GMP, ISO13485 and other industry standards
: Thorough knowledge of basic Engineering skills with the ability to plan, organize, control, and communicate effectively