Validation Engineer II

SGS Consulting; Manchester (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

SGS Consulting is seeking a qualified professional to own CSV activities for equipment, automation, and computer systems in a GMP environment. You will perform risk assessments, review change requests, and validate test scripts to ensure compliance.

The role requires drafting and executing validation protocols, managing GMP documentation updates, and leading Change Control, Deviations, and CAPAs within the QMS.

Qualifications

• Bachelor's degree required.
• Experience in GMP environments preferred.
• Familiarity with validation activities and change control processes.

Responsibilities

• Own CSV activities for equipment, automation, and computer systems.
• Perform risk assessments, review change requests, and validate test scripts.
• Draft and execute validation protocols and manage GMP documentation updates.
• Lead Change Control, Deviations, and CAPAs within the QMS.
• Support and validate DCS (DeltaV) and MES (Syncade) systems.
• Collaborate with cross-functional teams to improve validation efficiency and compliance.

Skills

CSV in GMP

DeltaV DCS

Syncade MES

QMS processes

CAPA management

Cross-functional collaboration

Education

Bachelor's

Job description

Job Responsibilities

Own CSV activities for equipment, automation, and computer systemsPerform risk assessments, review change requests, and validate test scriptsDraft and execute validation protocols and manage GMP documentation updatesLead Change Control, Deviations, and CAPAs within the QMSSupport and validate DCS (DeltaV) and MES (Syncade) systemsCollaborate with cross-functional teams to improve validation efficiency and compliance

Skills

Computer System Validation (CSV) in GMP environmentsProcess Control Systems & AutomationDeltaV DCS (preferred) and MES (Syncade)Biotech/Pharma or biologics manufacturing experienceQMS processes (Change Control, Deviations, CAPA)

Education/Experience

Bachelor's.