Job Summary
The Lab Systems CSV Engineer will be responsible for the execution of Laboratory Computer System Validation activities within the AIQ framework. (Analytical Instrument Qualification)
The successful candidate will be part of the Lab Services Team which will deliver validation elements for lab systems.
Individual is expected to be self-motivated and develop an understanding of the business.
Experience of working in a pharmaceutical manufacturing operation or a regulated environment is desirable.
Responsibilities
Minimum 3 years experience supporting and validating lab equipment updating documentation system testing troubleshooting
Work with ELM team colleagues to deliver validation elements of Laboratory capital projects.
End to End ownership of Change Controls and their results.
Author\Review\Approve qualification documents for lab systems.
Work with site teams on generation of requirements and\or configuration of specifications and IOQ test protocols.
Execution of IOQ protocols for lab analytical instruments.
Generation of risk assessments.
Be a key SME for the AIQ process for all GMP audits
Knowledge of 21CFR Part 11 requirements and data integrity guidelines is desirable
Strong oral and written communication skills are required with proven ability to communicate and build relationships cross-functionally
Self-motivated detail-oriented and excellent organizational and time management skills
Capable of relating well to other people with whom s/he comes in contact both within and outside of the laboratory area
Manage lab equipment validation projects from software install to business release
Work with ELM team colleagues to deliver validation elements of Laboratory capital projects.
End to End ownership of Change Controls and their results.
Author\Review\Approve qualification documents for lab systems.
Work with site teams on generation of requirements and\or configuration of specifications and IOQ test protocols.
Execution of IOQ protocols for lab analytical instruments.
Generation of risk assessments.
Be a key SME for the AIQ process for all GMP audits
gog2525!
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Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant (a member of the NASDAQ-100 and one of Forbes World’s Best Employers 2025) is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
Disclaimer:
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.