Job Description :
Hello,
We are looking for a Sr Validation Engineer – Chicago IL. If you are interested then please respond me back with your updated word copy of resume, contact information and the best time to call you. Appreciate your immediate response.
Job title: Sr. Validation Engineer
Duration : 6+ Months
Location: Chicago and Lexington
Experience Range 7-10 Years
Primary Skill Set :
Must have an experience in Regulatory compliance domain
Must have good communication skills
Must have experience with HP ALM and Doc Mgmt tool like Veeva, Master Control
Roles and Responsibilities
Ability to define problems, collect data, establish facts, and draw valid conclusions from these observations. Conduct root cause analysis to help redesign and implement improved Quality Systems.
Strong communication and presentation skills. Strong ability to facilitate discussions and negotiate mutually beneficial solutions when necessary.
Detailed knowledge of the general computerized system development life cycle in a regulated environment and software quality assurance
Advanced knowledge of general software and database concepts.
Experience with risk analysis and risk management practices and tools
Knowledge of infrastructure technology and platforms
The ability to work both independently and with teams at various levels in the organization
Excellent organizational skills and attention to detail and accuracy
Familiarity with FDA regulations (such as 21 CFR 11), GxP, SOX, electronic records and electronic signatures.
Experience in Validation functions in regulated or controlled environments.
Note: Momento USA is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.