Position : Validation Engineer
Location : San Antonio, TX
Duration : 12+ Months
Interview Mode : Phone then Skype
Responsibilities:
I would say the top 3 skills will need to be SW Validation experience, Quality Center and Oracle EBS knowledge.
The IT Software Validation Engineer is responsible for leading project development teams in the validation of IT non-product applications.
This position develops reviews, approves and executes validation deliverables including the Validation Plan, Installation Qualifications (IQ),
Operational Qualifications (OQ), Performance Qualifications (PQ), and summary reports to maintain IT non-product applications in a validated state.
This position also provides guidance and training to users, and project development teams for the development and execution of validation activities.
Other Required Skills:
knowledge of regulations and software lifecycle approaches (e.g., QSR's, ISO 13485, 21 CFR 11, GAMP, SDLC methodologies, ITIL)
Strong verbal and written communication skills, with ability to articulate the problem and solution space to different audiences.
Excellent analytical, organizational and communication skills. Ability to manage multiple tasks concurrently.
Ability to read and understand business and technical documents.
Self starter with strong process improvement and quality skills
Ability to deal effectively with all employees (including Executive Management) and external business contacts
while conveying a positive, service oriented attitude.
Ability to maintain complete confidentiality and discretion in business relationships and exercise sound business judgment.
Preferred Qualifications:
Experience with Quality Management Systems (e.g., Audit, CAPA, Document Control, Clinical Trials, Validation, etc)
Knowledge of HP Service Manager and/or HP Quality Center or similar applications.
Experience with Oracle E-Business Suite (Version 11i and/or Release 12) in a global environment
Experience in a medical device manufacturing IT environment
Regards,
Manju Shree
Sr IT Recruiter
IDC Technologies, Inc. 1851 McCarthy Boulevard, Suite 116,Milpitas, CA, USA, 95035
Phone: 408-418-5779 ext 252 |Fax: 408-608-6088 |
Email: manju@idctechnologies.com| Web: www.idctechnologies.com
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