SoTalent · 1 day ago
Computer Systems Validation Engineer
New Hampshire, United States
Full-time
Onsite
Mid, Senior Level
4+ years expSoTalent is 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.
Staffing & Recruiting
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
Qualification
Required
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
Strong knowledge of CAPAs and deviations
Background in biotech, pharma, medical device, or biologics required
Detail-oriented, independent, and deadline-driven
Preferred
Prior experience leading/managing validation projects is a plus
DeltaV preferred
Company
SoTalent
At SoTechTalent, we specialise in connecting forward-thinking tech companies with world-class talent.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase