Engineer, Project

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Description Under general direction, the Project Engineer will perform engineering duties and provide leadership as required in support to manufacturing. Duties will focus on improving and supporting the manufacturing processes to ensure product is manufactured at required quality and yields to support the business needs. The manufacturing process and supporting equipment is unique and fairly complex and typically operates under validated conditions in accordance with GMP and regulatory compliance requirements. Qualifications Education and Experience BS degree in Engineering with a minimum of 3 years in the Medical Device or Pharmaceutical industry required; or Masters degree in engineering with 2 years experience. Experience in GMP environments and familiarity with FDA and regulatory compliance. Broad knowledge and hands-on experience with machinery and mechanical testing procedures is desired. Experience managing medium sized engineering projects and vendor liaison. Textile manufacturing experience is a strong plus. Advanced degree desired, but not required. Essential Skills and Abilities · Ability to be recognized as a technical expert. · Ability to demonstrate leadership in job performance by example. · Ability to interface with higher and lower level employees within and outside of the department as necessary to successfully complete project tasks. · Ability to adjust rapidly to changing priorities of assignments and to prioritize and manage concurrent projects · Ability to guide and delegate to technical staff below this grade level. · Ability to learn and function in a controlled environment regulated by FDA GMPs and handle confidential data · Ability to work in a team environment with other engineers, manufacturing , R&D, QA and technicians. · Ability to effectively present information and respond to questions from groups of managers or technical peer groups. Employee Status: Regular Primary Location: USA-Massachusetts-Fall River Shift: Day Shift Job: Quality EEO/AA M/F/V/D
Phama Job Categories: 
Quality Assurance

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