On-Site CSV Engineer | GMP/21 CFR Part 11 Lead

Sotalent; New Hampshire; Sur place; USD 95 000 - 130 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Automation validation

Leadership

Regulatory compliance

Documentation

Formation

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

Outils

DeltaV Automation System

SCADA

DCS

BAS/BMS

MES

Description du poste

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.