Validation Engineer Job in Rochester, New York US
Validation Engineer
Validation Engineer I Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have a contract position for a Validation Engineer I for one of our fortune 500 clients in Rochester, NY. The Quality / Validation Engineer works in partnership with Manufacturing Operations, Engineering and other technical support groups to ensure Quality and customer expectations are met prior to final release of the product. Responsibilities include but are not limited to: Supports validation projects of all types for new and existing products, and provide direction with regard to Quality compliance. Reviews and approves change control documentation and ensures compliance to established procedures. Issues and investigates non-conformances using a systematic approach to problem solving. Conducts risk analyses and recommends and assures implementation of corrective and preventative actions. Analyzes data and identifies trends to improve quality and efficiency of manufacturing and quality systems. Investigates system gaps and failures, and works with business partners to ensure successful resolution. Maintains and promotes proactive inspection readiness and ensures consistency and compliance with the Quality System. Participates in manufacturing investigations, and both internal and external audits as necessary. Routinely interacts with data management systems such as SAP, Document Management Systems (Matrix One), and Non-Conformance and CAPA tracking (Trackwise). Qualifications: Bachelors Degree in a technical field, preferable Science or Engineering. MS/MBA preferred. Minimum of 1 year of relevant work experience within a regulated industry (medical device, biologics, or pharmaceutical) is required. Knowledge of Quality System Regulations (21CFR820, ISO 13485) is required. Proficiency in Microsoft Office Excel, Word, PowerPoint and Outlook is required. Familiarity with Information Technology Software Quality Assurance experience is preferred. Proficiency in Minitab is preferred. Process Excellence / Six Sigma, ASQ Quality Engineer or Quality Auditor, Lean or other relevant certifications is preferred. Must be highly self-motivated. Strong written and verbal communication skills. Must have the ability to prioritize tasks in order to meet deadlines, along with the ability to develop a wide range of solutions for manufacturing and supplier problems. In addition to working with the worlds most recognized and trusted name in staffing, Kelly employees can expect: Competitive pay, paid holidays, year-end bonus program, portable 401(k) plans, recognition and incentive programs, and access to continuing education via the Kelly Learning Center. For immediate consideration, please Apply Now, or refer a friend by clicking the email this job link provided. Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the apply now link below to submit your resume. Kelly Services ® is a U.S. based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world. We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com . Kelly Services Celebrating 60 Years Kelly Services is an Equal Opportunity Employer