Themesoft Inc. is a global IT solutions provider and a Woman‑Owned Minority Business Enterprise headquartered in Dallas, TX. With a strong presence across the US, Canada, India, Singapore, and Brazil, we specialize in digital transformation, consulting, and workforce solutions across diverse industries.
We are currently looking for a tech-savvy and results-driven professional for one of our leading clients. If you’re passionate about technology and looking to grow in a dynamic, fast-paced environment, this could be the perfect fit for you!
Lead/Sr Computer System Validation Engineer
Location - Muskegon, MI (Onsite)
Long term Contract
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.
Regards,
_______________________
Parthasarathy K
Lead Recruiter
Work: 972-474-8787 Ext: 306,Direct: 972-737-8607
Partha.k@themesoft.com
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