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US-Atlanta: Quality Engineer Biotechnology
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Date: 05-Aug-2008
Quality Engineer III - Biotechnology
PRINCIPAL RESPONSIBILITIES
Coordinate validation aspects of corporate projects. Develop Validation Master Plans to ensure all necessary validation work for corporate projects is addressed in a timely fashion. Design, prepare, execute, and analyze Installation Qualifications (IQs), Operational Qualifications (OQs), Performance Qualifications (PQs), and Process Validations (PVs) to approve equipment, processes, and software used in the testing, processing, storing, and distribution of products. Assist in the implementation of corporate policies and procedures relating to quality, project management, process development, and QSR/ISO compliance by establishing procedures and integrated program plans for achieving reliability in accordance with specifications and procedures. Ensure appropriate training and resource management of any staff assigned. Provide assistance and technical support to all, projects, facilities, and subsidiaries. Provide leadership within the Quality Engineering group in an effort to ensure technical and personal development of all personnel within Quality Engineering. Provide Quality Engineering support in resolving supplier-related quality issues. Collect, statistically analyze, and develop report packages to support all validations/qualifications. Develop, conduct, and document qualifications/validations to ensure that the products processed are proven to be reliable, safe, and effective prior to release. Assist in the evaluation of product complaints.
NOTES: Employer will assist with relocation costs
Requirements
REQUIREMENTS
Minimum of a Bachelors Degree in an Engineering field, or equivalent work experience. Minimum of 4 years hands-on validation experience; preferably in a pharmaceutical, biomedical, or medical device field (regulated industry) with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards. Specific experience required in the areas of sterilization equipment/processes for gamma, ETO and steam, HVAC systems, USP Purified & WFI systems, and Validation Master Planning.
KEY RESULT AREAS
Ability to maintain a high activity level while effectively managing and prioritizing numerous projects and responsibilities. Ability coordinate multiple validation projects within the QE group. Ability to design, prepare, execute, and analyze IQs, OQs, PQs, and PVs to approve equipment, processes, and software used in the testing, processing, storing, and distribution of products. Ability to interact effectively with people at all levels throughout the company.
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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
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