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Validation Engineer
| Details |
Country: USA
Location: OH Cincinnati
Total applied: 17
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Validation Engineer
VALIDATION ENGINEER
Barr Pharmaceuticals, Inc. a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develops, manufactures and markets more than 100 generic and proprietary pharmaceutical products in core therapeutic categories including female healthcare, oncology, cardiovascular, anti-infective and psychotherapeutic pharmaceuticals. The Company's generic products are marketed under the Barr label and proprietary products are marketed under the Duramed label. Barr is the leading supplier of oral contraceptive products in the United States.
In fiscal 2005, Barr recorded total revenue of $1.05 billion and invested $128 million in product research and development. Barr has operations in New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington, DC - and employs more than 2,000 employees.
We have an outstanding career opportunity for a successful Validation Engineer located in our Cincinnati, Ohio offices.
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 approaches
Position Requirements include:
Bachelors of Science degree in an engineering or scientific discipline
2+ years of experience in pharmaceutical Product and Process validation required
Thorough familiarity with cGMPs, SOPs, and relevant government regulations
Experience with equipment such as mixers, tablet presses, capsule machines, fluid beds and tablet coaters are preferred
Must have strong communications skills - both verbal and written
Working knowledge of Microsoft Office applications
Commitment 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.
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