CSV Engineer: FDA-Regulated Systems & Rockwell DeltaV

CAI; Bridgewater (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Insurance

Paid Time Off

Life Insurance

Long Term Disability

Job summary

CAI seeks a qualified Computer Systems Validation (CSV) professional to join our team in the pharmaceutical/biotech sector. You will author validation documentation, execute test protocols, and ensure 21 CFR Part 11 compliance across MES, DCS, and batch systems.

This role supports client engagements and helps ensure data integrity and regulatory readiness. The ideal candidate has a BS/BA in IT or engineering, 3+ years in CSV, and hands-on experience with Rockwell DeltaV, DeltaV Batch, and

Qualifications

• BS/BA in Computer Science or Engineering required.
• 3+ years of experience in computer systems validation.
• Experience in biotech or pharmaceutical environments preferred.
• In-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211).
• Familiarity with S88/S95 batch control standards.
• Experience with Rockwell DeltaV and recipe authoring in batch environments preferred.

Responsibilities

• Author GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports).
• Generate and execute test protocols and scripts.
• Ensure adherence to 21 CFR Part 11 and data integrity principles.
• Review and contribute to validation plans and risk assessments.
• Support CSV activities across MES, DCS, SCADA, and batch systems.
• Engage with Rockwell PharmaSuite and other automation platforms.
• Apply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11).
• Utilize familiarity with S88/S95 batch control standards.
• Collaborate with client teams to ensure validation compliance and delivery.

Skills

GxP compliance

Data integrity

Regulatory knowledge

Client communication

Project management

Education

BS/BA in CS or Engineering

Tools

Rockwell PharmaSuite

DeltaV

DeltaV Batch

Emerson Syncade

FactoryTalk

Wonderware

PAS-X

PLM

iFix

Siemens

Job description

CAI seeks a qualified Computer Systems Validation (CSV) professional to join our team in the pharmaceutical/biotech sector. You will author validation documentation, execute test protocols, and ensure 21 CFR Part 11 compliance across MES, DCS, and batch systems.

This role supports client engagements and helps ensure data integrity and regulatory readiness. The ideal candidate has a BS/BA in IT or engineering, 3+ years in CSV, and hands-on experience with Rockwell DeltaV, DeltaV Batch, and