Sr. Quality Engineer

Job TitleJob Duties:- Must perform equipment qualification, test method and process validation activities, process capability and process control studies for assigned areas.- Must plan and execute software validation activities in manufacturing and support areas.- Must drive quality/manufacturing projects utilizing Lean, problem solving, process control, and project management tools to achieve and sustain operational excellence.- Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new processes/technologies.- Must assist in the identification and development of process improvement projects including automation and computerization.- Must ensure computer systems and applications are compliant with regulatory quality standards through validation activities. May serve as SME for Computerized System Validation processes.- Responsible for ensuring FDA regulations are met for system upgrades/replacements.- Responsible for audits, creation, and implementation of Specifications/SOPs.- Responsible for ensuring the quality of facility systems (validation):• Writing and executing protocols and test cases for validations.• Coordinating testing and documentation of projects.• Documenting/executing changes to applications.• Assisting/leading training for systems.- Diversified knowledge of applied Statistical Analysis techniques, procedures, and criteria to carry out measurements, process, and product capability studies for the development of new or refined equipment, materials, processes, instruments, and products.- Must perform failure investigations and track follow-up corrective actions.- Ability to function effectively as a member of a team.- Ability to plan and prioritize multiple projects to ensure completion within the target dates.- Ability to communicate effectively in written and verbal form.- Must have knowledge of both plant and department environmental health and safety regulations and comply with said regulations accordingly.- Must perform all other duties and responsibilities as determined by supervision/management.Qualifications:- BS degree in Engineering, Computer Science or other core Science Discipline and 3-5 years minimum related experience (in house, co-op or acquired outside).- Knowledge of applications such as Wonderware, Allen-Bradley PLC/HMI, Access, Microsoft Project preferred.- Basic knowledge of manufacturing processes and the ability to quickly learn and understand processes/applications.- ASQ Certification (CQE or CSQE) or equivalent desired.- Leadership skills.- Ability to work independently or with a diversified cross functional team across different locations.- Ability to mentor new Engineers to the Company.- Logical thought process.- Self-motivated and works well without direct supervision.- Quality Assurance or Pharmaceutical industry experience desired.- Ability to lift to 10 pounds, to sit, stand and/or walk for long periods of time.- Ability to reach above the shoulder, to bend/stoop.