Senior Computer System Validation (CSV) Engineer - Consultant

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)