Sr. CSV Engineer

2 weeks ago

Muskegon, United States Cognizant Full time

Sr CSV Engineer

Cognizant Technology Solutions in LSMG is seeking for a Sr CSV Engineer who could join our team of Engineering professionals in a permanent role. Our strength is built on our ability to work together. Our diverse set of backgrounds offer different perspectives and new ways of thinking. It encourages lively discussions, inspires thought leadership, and helps us build better solutions for our people and clients. We are looking for someone who thrives in this setting and is inspired to craft meaningful solutions through true collaboration. If you are excited by change, and excel through autonomy, we would love to hear from you

Job Location: Muskegon MI

Roles and Responsibilities:

The Validation Specialist carries out quality control checks on engineering project work under the supervision of the Validation Lead, Automation Lead and Project Manager.
Perform initial CSV at client site for systems including DeltaV, Historian, MES, as well as other DCS and OT systems.
They will review and approve risk assessment link to CSV of systems.
Collaborate with the other departments, within their respective areas of responsibility, for Change Management, and for developing regulatory documentation.

The Validation Specialist responsibilities include:

Involvement in Project master validation planning
Ensuring automation compliance with GDP, cGMP & GAMP project guidelines
Quality review of design documentation
Generate software/hardware test protocols and reports
Assist in the execution/witnessing of hardware/software testing
Attendance at Factory Acceptance Testing

Required Qualifications:

The Validation Specialist attributes include:
Familiarity with ISA 88, GAMP, GMP, GDP, 21CFR Part 11
Familiar with DCS, Historian, MES and other systems found on OT manufacturing sites
Typically over 5 years relevant pharmaceutical industry experience

Salary and Other Compensation:
The annual salary for this position is depending on experience and other qualifications of the successful candidate.

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.

About Cognizant
Cognizant (Nasdaq: CTSH) engineers’ modern businesses. We help our clients modernize technology, reimagine processes and transform experiences so they can stay ahead in our fast-changing world. Together, we're improving everyday life. See how at www.cognizant.com or @cognizant.

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