CSV Validation Engineer II - GMP, DeltaV & MES

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

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.