· Carry out all aspects of a validation including: Authoring/reviewing/executing Validation Master Plan (VMP), Validation Plan (VP), User Requirements Specifications (URS), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ),and Performance Qualification (PQ) protocols/report, risk assessments, and periodic reviews in accordance with corporate and departmental procedures
· Analyze information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across site to ensure correct interpretation of the information
· Participate on cross-functional teams to address specific problems, facilitate discussion, research and assist with deviations investigation, change controls write-up
· Provide technical input with respect to Standard Operating Procedures development; review or revise SOP's as required to assure that all needs are addressed, and compliance and industry standards are incorporated
· Develop the site requalification plan and strategy, execution, and implementation; must be able to evaluate current processes and procedures and lead a validation team
· Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat-treating, bonding, molding, etc.
· Conducting feasibility study to estimate product cost and analyze capital equipment, capacity, and capability requirements. Improving process methods, which meet performance and quality requirements. Executing to project plans and schedules for work activities.
· 5-8 years' engineering experience within a medical device environment, with at least 3 at senior level.
· 3rd level degree in a related discipline, (masters preferred).
· Senior level experience in all aspects of validation activities, process improvements and equipment.
· Well developed project management skills.
· Knowledge of regulatory requirements.
· Report writing expertise and highly developed people skills.
· Attention to detail with excellent organizational skills.
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The Life Science Specialists