Job Description

Sr/Lead CSV Specialist

Cognizant Technology Solutions in LSMG is seeking for a Sr/Lead CSV Specialist 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 (Onsite)

Role Responsibilities

The CSV Lead manages quality control checks on engineering project work.

The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment.

The CSV Lead will be responsible to assist Client in designing the validation strategy for the overall project and to coordinate production of the required CSV protocols.

The CSV Lead will provide leadership to the CSV team members in reviewing CSV protocols for the various streams and ensuring that they are executed in accordance with Client policy and the relevant Project Plan.

The CSV Lead will liaise closely with Client Quality to ensure that customer quality expectations are met with respect to CSV and provide guidance to the Client.

Systems including DeltaV, Historian, MES, ABB as well as other DCS and OT systems.

Requirements

The Validation Lead responsibilities include:

• Project master validation planning
• Setting of project CSV guidelines
• Setting of GDP, cGMP & GAMP project guidelines
• Quality review of project documentation
• Quality review of testing documentation
• Review of validation documentation
• Attendance at testing stages
• Attend and participate in daily client site meetings
• Familiarity with relevant pharmaceutical / Life Sciences industry standards.
• Familiarity with validation of DeltaV, MES, Historian, ABB and other OT systems.
• Typically 11+ years relevant pharmaceutical / Life Sciences 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.

What We Offer:

• The chance to work with impact. Here, you're empowered to bring your biggest thinking to help our company and clients improve everyday life.
• Ownership over your career. Stay at the top of your game through our award-winning learning and development ecosystem. And when your ambitions change or we offer new opportunities, we help you pivot by providing reskilling, on-the-job learning and guidance to find new roles that might be a better fit.
• The opportunity to thrive on a high caliber team with heart. We celebrate each other's experiences and perspectives and promote a sense of belonging through our affinity groups and diversity and inclusion initiatives.
• A comprehensive total rewards package, including a competitive salary and pension plan with matching contributions.
• Flexible health and financial benefits to support you and your eligible dependents from day one.
• True work-life balance. Be at your best through paid time off, flexible work arrangements, volunteering opportunities, social events, and so much more.

About Us 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.

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, provincial or local laws.

If you have a disability that requires reasonable accommodation to search for a job opening or submit an application, please email CareersNA2@cognizant.com with your request and contact information.

While our system allows applications in all languages, job required language(s) and proficiency level(s) vary. However, basic English proficiency is required for Company-wide communications purposes. Further, for roles located in Quebec, professional English proficiency is required to communicate with our global clients.

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