*Please send profiles to <<[email protected]>>
Validation Engineer* * Princeton, NJ* *Candidates must be US Citizen, Green Card Holders or have an EAD.* *Responsibilities:* * * * Preparation of change control documents, including validation approach* * Prepare all validation documentation including Validation Plans, OQ Protocol and other required documents* * Development of test strategies for Off-The-Shelf and custom applications* *Preparation of OQ/System and UAT test scripts* *Coordination of testing, including evaluation of test results; oversees and reviews validation area processes and procedures.* * Compilation and quality review of validation binders* *Preparation of validation summary reports* * Document activities and work according to SOPs. Writes clearly and accurately* *Coordinate all validation activities by constant communication with affected departments and personnel* * * *Qualifications:* *Minimum of 3 to 5 years years computer system validation experience in Pharmaceutical industry; three years desirable.* *BS Degree with experience in validation and software development lifecycles, GXPs, 21CFR Part 11.* * Excellent written and verbal communication skills.* * Experience in a regulated environment, especially pharmaceutical (21 CFR Part 11),* *Good time management and organization skills; the ability to prioritize own work to meet tight deadlines while maintaining the highest standards of work * ** -- Thanks & Regards Stephen Ross |Technical Recruiter Dwlabs Inc Direct: 732-231-7733 Fax: 732-348-9590 Email: [email protected]
