Quality Software Validation Scientist/Engineer

LifeCell Corporation (Nasdaq:LIFC) is a bioengineering company engaged in the development and commercialization of tissue regeneration. When an organ or tissue donor gives permission to improve the quality of life for those in need, we begin the process of helping others. It takes committed, caring people to help in the daily operations of our company - people like you. We have the following opportunity available.

The Quality Software Validation Scientist/Engineer will be responsible for, but not limited to, working with Quality/Validation Management in developing and implementing software validation protocols to ensure compliance to applicable regulatory validation requirements, internal company standards and industry practices. This position will assess current software system validation packages for compliance to current medical device software validation practice and 21 CFR Part 11. As a member of Quality?s Validation Services, this position will also responsible for executing IQ/OQ/PQ protocols, and making recommendations for changes and/or improvements. The Quality Software Validation Scientist/Engineer will ensure over-all computer system compliance and continuous quality improvement in an ever-changing, regulated environment.

MINIMUM QUALIFICATIONS:
? BA or BS degree in a technical or scientific discipline or equivalent.
? 3 years of related Quality and/or Software related experience.
? Ability to work varied schedule with some potential weekend and evening hours.
? Demonstrated strong technical writing skills along with excellent oral and written communication skills.
? Demonstrated ability to interface effectively and professionally at all levels of the organization.

PREFERRED QUALIFICATIONS:
? MS degree in computer science or technical discipline.
? 5+ years technical/validation experience.
? Specific experience in software validation for 21 CFR Part 11.
? Experience in general quality assurance methods and practices, including quality improvement, quality management systems, corrective and preventive action, root cause analysis.
? Experience in an FDA Regulated field a plus.
? Grasps concepts quickly, especially as they relate to Federal, AATB, ISO and other regulatory guidelines.
? Experience with the validation of ERP systems is preferred.
? Must be able to work on problems of a complex scope where analysis of data requires an in-depth evaluation of various factors.
? Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

This position is classified as exempt in accordance with federal and state law.

To apply, visit our website at www.lifecell.com and reference Job ID #1066-06. Equal Opportunity Employer M/F/D/V.