Job Description :
Validation Engineer
Location: San Antonio, TX
Duration: 12 Months

Top 3 skills:
SW Validation experience
Quality Center
Oracle EBS knowledge

Requirement:
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.

Essential Duties
Provides validation planning, execution and summaries for non-product IT application changes.
Identifies gaps and contributes solutions to software validation processes, procedures and practices.
Ensures documentation and practices meet quality standards, applicable regulatory compliance, company guidelines/policy using sound software validation practices.
Ensures accuracy and completeness of software validation records (e.g., Validation Plan, IQ, OQ, PQ)
Authors and implements high level and detailed test specifications, test plans, test cases and scripts.
Contributes to the IT software validation processes, procedures and practices.
Reports test results in a structured way and advises on the quality of deliverables (internal/external Reports on application and documentation quality
Provide expertise and leadership in the review of all deliverables across the product lifecycle, ranging from requirements documentation, high level/detailed design, and code deliverables to packaged solutions for release.

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