Computer Systems Validation Engineer

SoTalent; New Hampshire; On-site; USD 95,000 - 130,000; Full time

Job summary

Sotalent is seeking a Computer Systems Validation Engineer for a 100% on-site role in Portsmouth, NH. The candidate will lead validation activities, maintain regulatory compliance, and mentor junior staff within a GMP environment.

The role requires 4+ years in automation or computerized system validation, with hands-on PLC/SCADA/DCS experience (DeltaV preferred). Biotech/pharma/medical device background preferred.

Qualifications

• Bachelor’s degree in Computer Science, Engineering, or related discipline.

Responsibilities

• Lead validation activities with clear communication, prioritization, and timely delivery.
• 0 Maintain expertise in 21 CFR Part 11, Data Integrity, ICH Q7A, GAMP, and related regulations.
• 0 Execute Quality Systems processes: Change Control, Deviations, CAPAs, and Validation Maintenance.
• 0 Draft and review protocols, risk assessments, test scripts, and GMP documentation.
• 0 Own and maintain CSV SOPs and departmental procedures.
• 0 Act as SME during audits and inspections.
• 0 Mentor and train junior validation team members.

Skills

Automation validation

Leadership

Regulatory compliance

Documentation

Education

Bachelor’s degree in Computer Science, Engineering or related discipline

Tools

DeltaV Automation System

SCADA

DCS

BAS/BMS

MES

Job description

We are seeking a Computer Systems Validation Engineer to support operations within a GMP-regulated environment. This role focuses on implementing industry best practices within GAMP frameworks, ensuring compliance with regulatory requirements, and maintaining validation integrity across critical systems. You’ll also provide guidance to junior team members and act as a subject matter expert during audits and inspections.

Key Responsibilities

• Lead validation activities, ensuring effective communication, prioritization, and timely delivery.
• Maintain expertise in 21 CFR Part 11, Data Integrity, ICH Q7A, GAMP, and related regulations.
• Execute Quality Systems processes: Change Control, Deviations, CAPAs, and Validation Maintenance.
• Draft and review protocols, risk assessments, test scripts, and GMP documentation.
• Own and maintain CSV SOPs and departmental procedures.
• Act as SME during audits and inspections.
• Mentor and train junior validation team members.

What You’ll Bring

• Bachelor’s degree in Computer Science, Engineering, or related discipline.
• 4+ years experience in automation and/or computerized system validation.
• 2+ years hands-on experience with PLCs, Controls Automation, SCADA, DCS, BAS/BMS, or MES (DeltaV preferred).
• Prior experience leading/managing validation projects is a plus.
• Strong knowledge of CAPAs and deviations.
• Background in biotech, pharma, medical device, or biologics required.
• Detail-oriented, independent, and deadline-driven.

This is a 100% on-site role in Portsmouth, NH. Relocation within commuting range is required.