Lead/Sr CSV Specialist

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.

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.