Validation Engineer

VALIDATION ENGINEER
Barr Pharmaceuticals, Inc. a holding company, is a global specialty pharmaceutical company engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. Operating through its principal subsidiaries including Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and Pliva d.d. and its subsidiaries, the Barr Group of companies markets more than 120 generic and 25 proprietary products within the U.S. and more than 1,200 products internationally.

With more than 8,500 employees worldwide who share a commitment to bringing these affordable generic and unique proprietary products to our customers, Barr has annual revenues in excess of $2 billion through our commitment to and significant investment in new product research and development.

We have an outstanding career opportunity for a successful Validation Engineer located in our Forest, VA offices.

Position Summary:

This position offers the ability to work with our dynamic Validation and Process Technical Services group to write validation and performance qualification protocols. This is an excellent opportunity for a success driven validation professional with pharmaceutical product and process validation experience to join a fast paced, rapidly growing organization.

Responsibilities include: Write validation (process and cleaning) and performance qualification protocols using information gained from technical services, research and development, and engineering, that clearly and succinctly define the process and test functions to be executed Monitor validation and performance qualification processes to ensure strict accordance with documentation Evaluate validation and performance qualification results such that the analysis is presented in a clear, orderly and succinct manner Perform cleaning validation sampling, using standard operating procedures, to evaluate cleaning procedures Provide validation support for scale-ups and technical support as needed Lead project teams for basic projects Coordinate routine validation activities (e.g., SOPs, Safety & Training) Perform physical testing, using lab equipment, to complete test functions Write installation and operational qualification protocols for basic equipment using knowledge of equipment, information from vendor, and input from engineering in a clear and thorough manner Identify and communicate technical product or process issues Troubleshoot and recommend solutions to mechanical, equipment, product, procedural and process problems as appropriate Assess new manufacturing concepts and approachesPosition Requirements include: Bachelors of Science degree in an engineering or scientific discipline and 2+ years of Pharmaceutical Product and Process validation experience Demonstrated knowledge of cGMPs, SOPs, and relevant government regulations Experience with equipment such as mixers, tablet presses, capsule machines, fluid beds and tablet coaters are preferred Ability to travel 25% of the time Demonstrated knowledge of Microsoft Office applications Must have strong communications skills ? both verbal and writtenCommitment to Excellence - Many companies talk about it. Barr delivers - every day, to our customers AND to our employees. Barr's commitment to employees is reflected in our total compensation and benefits package that includes competitive salaries and incentive compensation programs, career opportunities offering both personal and professional growth; a 401(k) plan that matches up to an additional 10% of your pay each year; a stock purchase plan that allows you to buy company stock at 15% below market; comprehensive medical and dental plans that provide coverage for you and your family with nominal employee cost; life and disability protection programs and so much more! Together, we raise the BARR!

We are an Equal Opportunity Employer m/f/d/v.