Validation Engineer III
Company: THERMO FISHER SCIENTIFIC
Posted on: December 7, 2018
Validation Engineer III Job Description Engineer III, Validation When you re part of the team at Thermo Fisher Scientific, you ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you ll be supported in achieving your career goals.LocationGreenville, NC How you will make an impactProvides direct quality support (e.g. compliance, regulatory assessment, and validation) to the business unit, clients and corporate management through the leading and executing tasks associated with key quality functions. Performs quality functions to ensure accurate and timely completion with frequent decision making, coordination and communications required. Creates, reviews, approves, tracks and presents documents and procedures required for compliance with pharmaceutical regulations. Identifies areas of non-compliance, review recommendations of others and implement solutions to resolve major quality and productivity issues. Implements systems to ensure compliance with new and changed regulations. Performs activities across key quality functions to support the business units. Prepares and conducts quality systems training across the company.What you will doPrepares, reviews and approves production, validation, audit reports and/or master batch record documents, procedures, and rationales.Manages, leads, schedules, executes and tracks multiple projects of high complexity with multi-disciplinary departments to ensure timely completion of deliverables.Serves as principle/validation liaison for negotiating with clients on agreements/projects and resolution of significant validation, product and regulatory issues. Coordinates, reviews and prepares customer audit responses and reports.Evaluates new regulations, changes to existing regulations and regulatory trends; performs gap analysis to determine deficiencies and take appropriate actions.Establishes actions and implements systems to achieve process improvements and efficiencies to address shortcomings in processes and systems.Serves as principle in hosting and coordinating regulatory inspections performed by the FDA, MCA and other regulatory agencies.Defends policies, procedures, rationales and methods in the area(s) of expertise during regulatory and client audits.Establishes and supervises quality programs and plans (e.g. validation, QAT, supplier certification).Identifies training needs and develop training programs.Works in a safe and responsible manner in order to create an injury-free and incident-free workplace. Complies with all job-related safety and other training requirements.Performs other duties as assigned.How you will get hereEducation:Bachelor s degree in a related field is required.Experience: Four years in the pharmaceutical industry or a regulated industry is preferred.Equivalent combinations of education, training, and relevant work experience may be considered.Knowledge, Skills, and AbilitiesProficient in the use of computerized office applications (e.g. Word, Excel, Outlook) and systems/business applications, project management and demonstrated scientific writing skills. Knowledge of cGMPs and FDA/industry expectations.Works on projects of moderate to high complexity in regards to compliance of processes and product within facilities, equipment, manufacturing and support areas.Makes decisions in conjunction with other disciplines (e.g. Quality and Production) while taking into account level of risks using written guidance in regards to compliance and product quality.Demonstrated ability to manage and lead professional staff in order to achieve goals, evaluate and resolve complex technical problems.Familiarity with a variety of concepts, practices and procedures. Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable.Demonstrates ability to maintain a high degree of confidentiality. At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission enabling our customers to make the world healthier, cleaner and safer. Apply today! Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Associated topics: business, cost efficient, industrial engineer, manufacturing engineer, methods engineer, project, sap, supply, supply chain
Keywords: THERMO FISHER SCIENTIFIC, Greenville , Validation Engineer III, Engineering , Greenville, North Carolina
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