Lead/Sr Computer System Validation Engineer Job at Themesoft Inc., Muskegon, MI

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  • Themesoft Inc.
  • Muskegon, MI

Job Description

Job Description

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

Themesoft Inc |Themesoft Jobs

Job Tags

Long term contract,

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