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Sunrise Systems Inc

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Computer Systems Validation Engineer (MES)_26-02885

Bothell, WA · On-site

$73 - $75/hr

InfoBatch). * Understanding of computer system validation (CSV). Education and Experience ... direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to ...

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As of Jun 29, 2026, the average hourly pay for director computer system validation csv in the United States is $51.80, according to ZipRecruiter salary data. Most workers in this role earn between $38.94 and $64.42 per hour, depending on experience, location, and employer.
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Infographic showing various Director Computer System Validation Csv job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 85% Full Time, 11% Part Time, 2% Contract, and 1% Nights. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $107,747 per year, or $51.8 per hour.
Computer System Validation (CSV) Lead

Computer System Validation (CSV) Lead

Intellectt INC

Lancaster, PA • On-site

Contractor

Posted 9 days ago

Job description

Hello,

I hope you're doing well.

My name is Mahalakshmi, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Computer System Validation (CSV) Lead based in Lancaster, PA with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at mahalakshmi.n@intellectt.com  OR +1 (732) 737 8381

Job Title: Computer System Validation (CSV) Lead
Location: Lancaster, PA

Position Summary

We are seeking an experienced Computer System Validation (CSV) Lead to support validation activities for a newly constructed Sterile Drug Product Clinical Manufacturing Facility. This role will lead CSV strategy, execution, and compliance activities for GMP computerized systems and automation platforms in a fast-paced project environment.

Key Responsibilities

  • Lead CSV strategy and execution for GMP computerized systems and automation platforms.
  • Author and execute CSV lifecycle documents including Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
  • Support commissioning, qualification, and validation activities for manufacturing and automation systems.
  • Collaborate with Automation, Engineering, Quality, Manufacturing, and IT teams.
  • Lead deviation investigations, troubleshooting, and validation issue resolution.
  • Ensure compliance with GAMP5, 21 CFR Part 11, Data Integrity, and company validation standards.
  • Support testing and validation of control systems, SCADA/HMI platforms, instrumentation, OT infrastructure, and manufacturing equipment.

Required Qualifications

  • Bachelor’s degree in Engineering, Computer Science, Automation, Life Sciences, or related field.
  • 10–15 years of CSV, Automation, or Validation Engineering experience in pharmaceutical or biotech industries.
  • Strong experience in GMP manufacturing environments, preferably sterile or aseptic processing facilities.
  • Hands-on experience with CSV documentation, protocol execution, and validation lifecycle management.
  • Strong knowledge of GAMP5, 21 CFR Part 11, CSA/CSV methodologies, and Data Integrity principles.
  • Excellent technical writing, troubleshooting, and communication skills.

Preferred Technical Experience

  • AVEVA System Platform, Allen Bradley PLC, Siemens PLC, PI Historian, SCADA/HMI systems.
  • OT networks, instrumentation, industrial communications, and field I/O testing.
  • Experience with robotic isolators, filling lines, lyophilizers, autoclaves, and wash systems.
  • Kneat validation platform experience preferred.

Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc 
mahalakshmi.n@intellectt.com
Direct: +1 (732) 737 8381