Manager, Validation

Welcome to Novartis - the company that considers its employees to be its greatest asset.
Good Business.
Great Opportunities.
How do you spend your day? Are you passionate about what you do? At Novartis, our focus is clear, our purpose defined. We're part of a team that's making a difference in the quality of people's lives.Think What's Possible.
***THIS POSITION IS LOCATED IN WILSON, NORTH CAROLINA***Position Summary:In a team based environment overall responsibility for the management and execution of commercial product support projects in the areas of product/process technical transfer, validation of manufacturing and cleaning as well as the qualification / validation of equipment for its intended use per the guidelines and expectations as outlined by the Code of Federal Regulations; develop systems and processes to support cGMP compliance; identification and evaluation of critical processing parameters as relevant for the validation activities. Conduct studies, write protocols and reports in support of process, cleaning and equipment validation. Ensures compliance with all Sandoz's cGMP, SOP's, FDA, HS&E and DEA regulations. Essential Job Functions:Supervises a group of employees or outside contractors/vendors who have similar technical or functional responsibilities. Requires an operating knowledge of process, cleaning and equipment validation. Assigns tasks, reviews work and writes appraisals. Ensures projects are on schedule and within budget. Receives assignments in the form of objectives with no process defined.Plans and supervises product transfer projects, transferring specific products from regular production at local site from an alternate manufacturing site. Establishes written standards for the site in the areas of process, cleaning and equipment validation. Establishes cooperation among Scientists, Associates and/or contractors to ensure successful technical project completion in assigned areas.Provides guidance to subordinate resources by following established processes to attain specific goals within a predetermined timeline.Ensures all work undertaken is performed in accordance with standards and expectations according to company principles and industry regulations.Manages and resolves technical issues that arise throughout a project life cycle.QualificationsEducation: BS in a technical field such as engineering, chemistry, biology, etc.Work Experience: 10 years progressively responsible experience in the fields of pharmaceutical product development and/or process development along with an in-depth knowledge of process development techniques, cGMP, FDA and DEA regulations and recent trends in validation concepts. Must have hands-on knowledge of pharmaceutical equipment, and be able to supervise batch manufacture and instruct production operators. A thorough knowledge of pharmaceutical unit operations.
Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.To apply for this position, Click HereTo learn about other Novartis opportunities, Click Here