GxP CSV & Manufacturing Systems Lead

Futureproof; West Point (MS); On-site; USD 110,000 - 160,000; Full time

Job summary

Futureproof is seeking an experienced Technical Project Manager to lead CSV and compliance activities for computerized manufacturing systems in a GMP-regulated pharmaceutical environment. The role coordinates cross-functional teams across Business, Quality, Validation, Engineering, Automation, and IT to ensure adherence to GxP, SOPs, and regulatory expectations.

Responsibilities include governance throughout the validation lifecycle, risk oversight, and management of timelines, dependencies, and

Qualifications

• Experience as Technical Project Manager in pharmaceutical manufacturing or regulated environments.
• Knowledge of Computer System Validation and GxP compliance.
• Experience with computerized manufacturing, automation, or lab systems.
• Understanding of CSV lifecycle, CSA, IQ/OQ/PQ, and change control.

Responsibilities

• Lead and coordinate CSV and compliance activities for computerized manufacturing system projects.
• Ensure project alignment with GxP, SOPs, quality standards, and regulatory expectations.
• Provide governance and oversight through validation lifecycle: planning, doc review, approvals, tracking.
• Manage timelines, deliverables, dependencies, resources, risks, and milestones.
• Coordinate validation, qualification, and quality activities across stakeholders.
• Guide teams on SDLC, CSA, risk-based validation, qualification, and change control.
• Facilitate risk assessments, issue resolution, deviation management, CAPA tracking, and change management.
• Act as liaison between Business, Quality, Validation, Engineering, Automation, and IT.
• Identify delivery or compliance risks and drive mitigation/escalation.
• Provide status, risk, and compliance updates to senior stakeholders.

Skills

Project governance

Stakeholder management

Risk management

Cross-functional coordination

Regulatory compliance

Data integrity

GxP knowledge

SDLC

CSV validation

CAPA tracking

Tools

Rockwell PLC

Siemens PLC

Manufacturing Execution Systems

Process historians

Laboratory automation systems

Job description

Futureproof is seeking an experienced Technical Project Manager to lead CSV and compliance activities for computerized manufacturing systems in a GMP-regulated pharmaceutical environment. The role coordinates cross-functional teams across Business, Quality, Validation, Engineering, Automation, and IT to ensure adherence to GxP, SOPs, and regulatory expectations.

Responsibilities include governance throughout the validation lifecycle, risk oversight, and management of timelines, dependencies, and