Software Validation Engineer Sr. 

Kinetic Concepts, Inc. is a publicly traded (NYSE: KCI) global medical technology company based in San Antonio, Texas with direct operations in 15 countries. With over 5,000 employees and 2004 revenues of approximately $1 billion, KCI is one of the fastest growing and most exciting companies in the medical technology sector, with a market capitalization of approximately $5 billion. KCI has provided a wide range of innovative medical devices for over 25 years, including leading-edge innovation in Wound Care, Pulmonary Care and Bariatric Care to patients in all care settings. More details on KCI can be found at www.kci1.com.

Job Description:

This position is responsible for developing, reviewing, approving and in some cases execution of validation documentation including, Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) to maintain processes and equipment in a validated state.  This position will also provide guidance and training to user departments on the development and execution of validation protocols.

 

The position will require experience in the validation of computer systems and manufacturing processes.  This person should be experienced with the development of SOP�s, change control and resolving deviations and validations in a medical devices environment including experience with 21 CFR Part 11. 

 

Job Requirements:

Basic Qualifications:

  

�         Bachelor degree in Computer Sciences or related field

 

�         At least 5 years of equipment and process validation in a pharmaceutical/medical devices environment

 

�         Experience with MS Office applications including:  Word, Excel, PowerPoint, and OutLook

  

Other Qualifications:  

 

  �         Knowledge of regulations and software lifecycle approaches (e.g.,QSR�s, ISO 13485, 21 CFR 11, GAMP, SDLC methodologies, ITIL)

 

�                  Knowledge of FDA regulations and guidelines

 

�         Experience with Quality Management Systems (e.g., Audit, CAPA, Document Control, Clinical Trials, Validation, etc)

 

�         Ability to read and understand business as well as technical requirements

 

�         Demonstrated versed with software lifecycle processes and methodologies, with emphasis on quality assurance and testing best practices.

 

�         Demonstrated presentation and communication skills.

 

�         Demonstrated analytical and organizational skills..

 

�         Ability to deal with all employees (including Executive Management) and external business contacts while conveying a positive, service oriented attitude.

 

�         Ability to maintain confidentiality and discretion in business relationships and exercise sound business judgment.

 

�         Demonstrated hands-on knowledge with HP Test Tool Quality Center.

 

�        Knowledge of scripting and programming knowledge

 

�               Experience with Oracle E-Business Suite (Version 11i and Release 12)