Lead CSV Engineer

Cognizant Technology Solutions in LSMG is seeking for a Lead 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 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, as well as other DCS and OT systems.

Required Qualifications:

* 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, and other OT systems.

* Typically, over 10 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.