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Computer System Validation Engineer (ONSITE)

Cognizant’s Digital Engineering

Our practice is seeking a highly qualified Computer System Validation Engineer with experience in developing and building impactful, scalable, enterprise applications.

Our Developers have a passion for high-quality, reliable, and maintainable code. You will work side by side with product managers, designers, and clients, making decisions together to quickly deliver valuable working software to clients and their users.

Our developers are agile and retrospective, and not afraid to identify what we’re doing wrong, so we can fix it, so we can improve on it. Above all, we judge success by the success of our team and the happiness of our customers.

Cognizant will only consider applicants for this position who are legally authorized to work in the United States

Responsibilities:

+ Carry out quality control checks on engineering project work under the supervision of the Validation Lead, Automation Lead, and Project Manager.

+ Perform initial Computer System Validation (CSV) at client sites for systems including DeltaV, Historian, MES, ABB, and other DCS and OT systems.

+ Review and approve risk assessments linked to CSV of systems.

+ Collaborate with other departments within their respective areas of responsibility for Change Management and for developing regulatory documentation.

+ Involvement in Project master validation planning.

+ Ensure automation compliance with GDP, cGMP, and GAMP project guidelines.

+ Conduct quality reviews of design documentation.

+ Generate software/hardware test protocols and reports.

+ Assist in the execution/witnessing of hardware/software testing.

+ Attend Factory Acceptance Testing.

Requirements:

+ Familiarity with ISA 88, GAMP, GMP, GDP, and 21 CFR Part 11.

+ Experience with DCS, Historian, MES, and other systems found on OT manufacturing sites.

+ Typically 6+ years of relevant pharmaceutical industry experience.

Benefits:

Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:

+ Medical/Dental/Vision/Life Insurance

+ Paid holidays plus Paid Time Off

+ 401(k) plan and contributions

+ Long-term/Short-term Disability

+ Paid Parental Leave

+ Employee Stock Purchase Plan

Disclaimer: The salary, other compensation, and benefits 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.

Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.