🚨 Req Sr. CSV Engineer (MES Experience Must) 🚨📍 Location: Bothell, WA (Day 1 Onsite)

[Adam Noel]

🚨 Hot Requirement – Sr. CSV Engineer (MES Experience Must) 🚨
📍 Location: Bothell, WA (Day 1 Onsite)
⏳ Duration: 12+ Months Contract
💼 Experience: 10+ Years preferred

Job Description:
We’re looking for a Senior CSV Engineer with strong MES (Manufacturing Execution System) expertise to join our client’s validation team. The role involves preparing and executing test documentation for GMP computerized systems and supporting troubleshooting activities during execution.

Key Responsibilities:
• Prepare and execute validation documents (URS, DR, SAT, IQ, OQ, PQ).
• Ensure compliance with 21 CFR Part 11, ICH standards, EMA & FDA (GxP), and GAMP methodologies.
• Collaborate with multidisciplinary validation teams for automated equipment and control system validation.
• Review vendor documentation, test scripts, and system implementation plans in ALM.
• Conduct Risk Assessments (RRA), manage change requests, and review/approve implementation summaries and retirement reports.

Must Have:
✅ MES (Manufacturing Execution System) experience
✅ Strong understanding of regulatory compliance (GxP, FDA, EMA)
✅ Hands-on with ALM and CSV documentation lifecycle

 

 

 

 

 

 

”In case I missed your call, Email is the best way to reach me ”

 

Thanks & Regards

Adam Noel

Sr Technical Recruiter

Phone: +1(614) 739 0208 / Whatsapp : +91 9160089447

Email : Ad...@startechsinc.us

Website: http://startechsinc.us

Linkedin1:- https://www.linkedin.com/in/harsha-adam-noel-77669b217/

Linkedin2:- https://www.linkedin.com/in/sri-harsha-adam-noel-909bba304/

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