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 8++ years relevant pharmaceutical / Life Sciences industry experience.
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