CSV Lead / Engineer – DeltaV & Syncade

EFOR; New Hampshire; On-site; USD 120,000 - 180,000; Full time

Job summary

EFOR is seeking an experienced CSV Engineer/Lead to support a pharmaceutical manufacturing project in New Hampshire. The role requires hands-on DeltaV expertise and strong knowledge of Syncade MES within GMP environments.

The consultant will work on-site with Automation, Engineering, Quality, Manufacturing, IT/OT, and system integrators to lead CSV activities, develop validation documentation, and ensure regulatory compliance including GAMP 5 and 21 CFR Part 11.

Qualifications

• Extensive CSV experience in pharma/biotech environments.
• Hands-on DeltaV experience is mandatory.
• Experience with Emerson Syncade / MES.
• Strong GMP automation, data integrity, and regulatory knowledge.
• On-site work in New Hampshire is required.

Responsibilities

• Lead CSV activities for GMP automation and manufacturing systems.
• Validate DeltaV and Syncade implementations; manage IQ/OQ/PQ processes.
• Develop and review URS, Validation Plans, Traceability Matrices, and test scripts.
• Review vendor and system-integrator documentation and manage deviations.
• Support FAT, SAT, commissioning, and qualification activities; ensure compliance with regulations.

Skills

CSV experience

DeltaV

Syncade

GMP/regulatory awareness

Education

Bachelor's in Engineering

Tools

DeltaV

Syncade MES

Job description

Industry: Pharmaceutical / Biotechnology

Duration: Long-term project

About EFOR

EFOR is an international Life Sciences consulting group supporting pharmaceutical and biotechnology companies across Engineering, CQV, CSV, Automation, Quality, and Digital Transformation projects.

We partner with leading Life Sciences organizations across the U.S. and internationally, providing technical expertise directly within client project teams.

Position Overview

EFOR is looking for an experienced CSV Engineer / CSV Lead with strong DeltaV and Syncade experience to support a pharmaceutical manufacturing project in New Hampshire.

The consultant will work on-site with Automation, Engineering, Quality, Manufacturing, IT/OT, and system integrators.

DeltaV experience is mandatory.

Key Responsibilities

• Lead CSV activities for GMP automation and manufacturing systems.
• Support validation of Emerson DeltaV and Syncade.
• Develop and review:
• URS
• Validation Plans
• Traceability Matrices
• IQ / OQ / PQ protocols
• Test scripts
• Validation Summary Reports
• Support testing of DeltaV control strategies, recipes, batch functionality, alarms, security, and audit trails.
• Support validation of Syncade workflows and Electronic Batch Records.
• Review DeltaV / Syncade integrations and other manufacturing-system interfaces.
• Participate in FAT, SAT, commissioning, and qualification activities.
• Manage deviations, change controls, and validation issues.
• Review and challenge vendor and system-integrator documentation.
• Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, CSA, and GMP requirements.

Required Experience

• Strong pharmaceutical / biotech CSV experience.
• Hands-on DeltaV experience — mandatory.
• Experience with Emerson Syncade / MES.
• Strong understanding of GMP automation systems.
• Knowledge of GAMP 5, CSA, 21 CFR Part 11, and data integrity.
• Experience with IQ / OQ / PQ and risk-based validation.
• Strong communication and critical-thinking skills.
• Ability to work on-site in New Hampshire.

Preferred Experience

• Syncade Electronic Batch Records.
• DeltaV / Syncade integrations.
• ISA-88.
• Biotech or pharmaceutical manufacturing projects.

Ideal Profile

We are looking for someone who combines CSV expertise with strong technical knowledge of DeltaV and Syncade, and who can work effectively with Automation, Quality, Engineering, and Manufacturing teams.