Senior Computer System Validation (CSV) Engineer - Consultant

Inteldot; Town of Texas (WI); On-site; USD 110,000 - 140,000; Full time

Job summary

Inteldot seeks an experienced Senior Computer System Validation (CSV) Engineer to support validation activities for GMP-regulated manufacturing and automation systems onsite in Texas. The ideal candidate will have hands-on DeltaV validation expertise and a strong background in pharmaceutical/biotech environments.

The role involves collaborating with Engineering, Automation, Manufacturing, QA, and IT to ensure computerized systems are validated and maintained in compliance with FDA regulations,

Qualifications

• Bachelor’s degree in engineering, Computer Science, Information Systems, or related technical discipline.
• 5+ years of Computer System Validation experience in pharmaceutical, biotechnology, or medical device.
• Hands-on experience validating Emerson DeltaV systems.
• Strong understanding of GAMP 5, FDA regulations, cGMP, and 21 CFR Part 11.
• Experience developing and executing IQ, OQ, and PQ protocols.
• Experience with change control, deviation investigations, CAPA, and risk assessments.
• Excellent technical writing and documentation skills.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Lead Computer System Validation (CSV) activities for GMP computerized systems.
• Develop, review, and execute validation documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
• Validate automation systems, including Emerson DeltaV DCS, SCADA, and supporting infrastructure.
• Support commissioning and qualification activities for new and existing manufacturing systems.
• Perform impact assessments, change control evaluations, and periodic reviews.
• Ensure compliance with FDA, cGMP, GAMP 5, ALCOA+, and 21 CFR Part 11 requirements.
• Collaborate with Automation, Engineering, IT, Manufacturing, and Quality teams during project execution.
• Support audits and regulatory inspections by providing validation documentation and technical expertise.
• Review system lifecycle documentation and maintain validated system status.

Skills

CSV Experience

GMP Compliance

FDA Regulations

Cross-Functional Collaboration

Technical Writing

Communication Skills

Education

Bachelor's degree in engineering, CS, or IS

Tools

Emerson DeltaV

Job description

Position Summary

We are seeking an experienced Senior Computer System Validation (CSV) Engineer to support validation activities for GMP-regulated manufacturing and automation systems at client. The ideal candidate will have extensive experience validating computerized systems within the pharmaceutical or biotechnology industry and hands-on experience with Emerson DeltaV automation systems. The successful candidate will work closely with Engineering, Automation, Manufacturing, Quality Assurance, and IT teams to ensure computerized systems are validated and maintained in compliance with FDA regulations, GAMP 5, and 21 CFR Part 11 requirements.

Location: Texas (Onsite)

Administrative shift

Responsibilities

• Lead Computer System Validation (CSV) activities for GMP computerized systems.
• Develop, review, and execute validation documentation, including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Summary Reports.
• Validate automation systems, including Emerson DeltaV DCS, SCADA, and supporting infrastructure.
• Support commissioning and qualification activities for new and existing manufacturing systems.
• Perform impact assessments, change control evaluations, and periodic reviews.
• Ensure compliance with FDA, cGMP, GAMP 5, ALCOA+, and 21 CFR Part 11 requirements.
• Collaborate with Automation, Engineering, IT, Manufacturing, and Quality teams during project execution.
• Support audits and regulatory inspections by providing validation documentation and technical expertise.
• Review system lifecycle documentation and maintain validated system status.

Required Qualifications

• Bachelor’s degree in engineering, Computer Science, Information Systems, or related technical discipline.
• 5+ years of Computer System Validation experience in the pharmaceutical, biotechnology, or medical device industry.
• Hands-on experience validating Emerson DeltaV systems is required.
• Strong understanding of GAMP 5, FDA regulations, cGMP, and 21 CFR Part 11.
• Experience developing and executing IQ, OQ, and PQ protocols.
• Experience with change control, deviation investigations, CAPA, and risk assessments.
• Excellent technical writing and documentation skills.
• Strong communication and cross-functional collaboration skills.

Preferred Qualifications

• Experience with Manufacturing Execution Systems (MES), SCADA, PLCs, or process automation systems.
• Knowledge of electronic batch records (EBR) and manufacturing systems integration.
• Experience supporting commissioning, qualification, and validation (CQV) projects in biologics or sterile manufacturing environments.

Technical Skills

• Emerson DeltaV (Required)
• Computer System Validation (CSV)
• GAMP 5
• 21 CFR Part 11
• cGMP/FDA Compliance
• IQ/OQ/PQ Protocols
• Risk Assessments
• Change Control
• CAPA
• Commissioning & Qualification (CQV)
• Automation Systems Validation
• Technical Documentation

Preferred Industry Experience

• Biotechnology
• Pharmaceutical Manufacturing
• GMP-Regulated Facilities
• Cell & Gene Therapy or Biologics Manufacturing (preferred)