The Validation Engineer will write and review validation documents. The responsibilities primarily include Review and Validation of any implementation throughout the SDLC. The responsibilites include review of Research and Dev documents , make sure they adhere to compliance and SDLC standards, and execute test scripts leveraging excel.
A successful Validation Specialist candidate will conduct or coordinate performance testing and perform or oversee the validation of facilities, equipment, utilities, laboratories, equipment, and processes. The engineer will be involved in validation monitoring activities, which will include audits with the system owner and review of operational documents. Also involved in development and process validation which includes cleaning, shipping, and continued process verification.
Essential functions and skills:
* Ability to review Validation Deliverables
* Experience validating within GLP (Good Lab Practice)
* Test Design and Test Development experience
* Validation of Lab Equipment for Bio Analytics
* Experience with Watson LIMS would be a +
* Will be assisting with the New Haven Move - ability to work within tight deadlines
The candidate should have excellent understanding of 21 CFR Part 11, ICH standards, EMEA, GLP, GCP, GMP, GDP regulations, GAMP Methodologies and general Software Development Standards.
Creating and Reviewing the following for LIMS applications:
* Validation Master Plans
* Requirements and Risk Analysis
* Traceability Matrix
* IQ/OQ/PQ protocols and reports
* Testing Documents and reports
* Data Migration Plans and reports
* Test Plans
* Test Scripts
* Discrepancy resolution
Join TEKsystems®, a leading IT staffing, IT talent management and IT services firm, and get your career on the fast track. We have more than 100 offices worldwide, and we partner with over 6,000 clients and place over 80,000 consultants per year. At TEKsystems, we seek to understand our consultants' skills, goals and interests, allowing us to present targeted job opportunities on a contract, contract-to-hire or direct placement basis. TEKsystems' leadership in the market stems from our sincere and personal commitment to driving the success of our customers, consultants and each other.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, genetic information or any other characteristic protected by law.
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A little about us:
TEKsystems provides corporations with IT staffing, talent management expertise and IT services, enabling them to meet their business objective.