Computer System Validation

BCforward; Indiana; Remote; USD 65.000 - 95.000; Vollzeit

Zusammenfassung

BCforward is seeking a Computer Systems Validation consultant to work remote in Indianapolis, IN. This CSV contractor will support GxP OT projects at our Clinton, Indiana manufacturing facility, delivering validation for large-scale capital projects and OT systems that monitor and control pharmaceutical processes.

The ideal candidate has pharma/GxP CSV experience with OT/automation knowledge, including PLCs, DCS, SCADA, and process equipment such as pumps, tanks, valves, and skids; Emerson

Qualifikationen

• Experience with CSV in a pharmaceutical/GxP environment.
• Hands-on experience validating OT/automation systems.
• Understanding of PLCs, SCADA, DCS, or industrial control systems.
• Experience with pharmaceutical manufacturing/process equipment.
• Ability to interpret technical drawings and vendor-provided system documentation.
• Strong validation documentation and communication skills.

Aufgaben

• Provide CSV support for GxP OT projects and system changes.
• Develop and maintain CSV/validation documentation.
• Review OT system drawings, specifications and vendor docs and translate into validation deliverables.
• Support validation activities for PLC, DCS, SCADA, and related manufacturing systems.
• Work with project, engineering, automation, quality and vendor teams.
• Ensure validation activities align with GxP/GMP requirements.
• Maintain required training and learning plans.

Kenntnisse

CSV experience

OT/automation systems

PLC/SCADA/DCS

Technical documentation

Vendor teamwork/ communication

Tools

Emerson DeltaV

GxP validation tools

Jobbeschreibung

BCforward is seeking a Computer Systems Validation consultant to work remote in Indianapolis, IN

Computer System Validation (CSV)

Location: Indianapolis- Remote

Seeking a Computer System Validation (CSV) Contractor to support GxP projects involving Operational Technology (OT) at its Clinton, Indiana manufacturing facility. The contractor will provide CSV support for large-scale capital projects and system changes involving OT systems that monitor and control pharmaceutical manufacturing processes.

The ideal candidate will have strong pharmaceutical/GxP CSV experience combined with OT/automation knowledge, including exposure to PLCs, DCS, SCADA, and process equipment such as pumps, tanks, filters, valves, and skids. Experience with Emerson process automation/DeltaV is preferred.

Key Responsibilities

• Provide CSV support for GxP OT projects and system changes.
• Develop and maintain CSV/validation documentation.
• Review OT system drawings, specifications, and vendor documentation and translate them into appropriate validation deliverables.
• Support validation activities for PLC, DCS, SCADA, and related manufacturing systems.
• Work with project, engineering, automation, quality, and vendor teams.
• Ensure validation activities align with applicable GxP/GMP requirements.
• Maintain required training and learning plans.

Required Qualifications

• Experience with Computer System Validation (CSV) in a pharmaceutical/GxP environment.
• Hands‑on experience validating OT/automation systems.
• Understanding of PLCs, SCADA, DCS, or industrial control systems.
• Experience with pharmaceutical manufacturing/process equipment.
• Ability to interpret technical drawings and vendor-provided system documentation.
• Strong validation documentation and communication skills.

Preferred

• Emerson DeltaV / Emerson process automation experience.
• Experience with DCS/PLC integration and SCADA development.
• Experience supporting large-scale pharmaceutical capital projects.