Equipment Qualification Coordinator

EQUIPMENT QUALIFICATION COORDINATOR


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 Equipment Qualification Coordinator located in our Pomona, NY offices.


Responsibilities include:

Provide centralized coordination for the qualification department and activities associated with procurement of cGMP equipment and systems
Monitor capital expenditures at all Barr facilities including CAR's for R&D, Quality Control, Corporate Engineering, site Engineering and Manufacturing
Coordinate activities associated with routing and approving user requirement specifications
Support Equipment Qualification Engineers in the collection of system design specifications and pre-qualification deliverables.
Develop and maintain a database, to provide customers with current and reliable information regarding equipment and utility qualification data.
Perform quality reviews of new and executed qualification protocols and final reports to ensure completeness and accuracy.
Ensure consistency is maintained in qualification practices across all sites.
Compile the department's monthly reports and maintain metrics for submission to senior management.
Track non-conformance investigations, preventive and corrective actions related to equipment qualifications.
Assist in the development and maintenance of department training program.
Prepare validation requests for proposal and solicit proposals from validation contractors.
Track deliverables and invoices associated with out-sourced validation projects.
Develop and maintain validation schedules associated with larger projects requiring master plans.

Position Requirements include:

Bachelor's degree in Engineering preferred.
2+ years of manufacturing and engineering project management experience.
Detailed knowledge of high speed automated manufacturing and/or packaging equipment.
Familiarity with cGMPs, SOPs, relevant government regulations, and current industry standards.
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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