| Direct Client - Validation Engineer
Pharmaceutical Industry Background Princeton - NJ Contract - 9 months Need In-person interview Job Description: Validation Engineer Reports to: Manager, Validation Services Overview: This person will perform validation of computer systems in an FDA-regulated environment. Responsible for preparation of change control and validation documents, preparation of summary reports, and preparation of test scripts. 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, 21 CFR 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 1
Regards, Kalpana Sajeev Technical Recruiter 399 Thornall Street 4th Floor Edison, NJ 08837 Desk: (732) 906-5660 Ext. 235 Cell: (732) 822 9539 Fax: (732) 906-7688 |
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