Pharma Project Documentation Engineer - Drive GMP Data

GEA Group; Janesville, Northern (WI, KY); Hybrid; USD 85,000 - 110,000; Full time

Job summary

GEA Group seeks a project engineer to oversee multiple engineering projects from design to delivery. You will coordinate cross-functional teams, ensure quality, cost control and schedule adherence, and support on-site installation and qualification activities.

A strong background in machine manufacturing and pharma-related equipment is essential, with willingness to travel as needed. Responsibilities include preparing design qualification packs, reviewing BOMs and drawings, and maintaining

Qualifications

• Minimum 5-6 years in project engineering in machine manufacturing or plant maintenance.
• Broad knowledge of pharma product lines; tablet compression machines preferred.

Responsibilities

• Prepare & review mechanical design qualification documentation package.
• Evaluate BOM, mechanical drawings, and technical specifications.
• Prepare PFDs and P&IDs based on process and project engineering.
• Responsible for equipment layout on general arrangement drawings.
• Coordinate with Belgium engineering team for technical queries.
• Coordinate with engineering teams for specifications and design queries.
• Manage revision control and track document revisions.
• Ensure documents comply with industry and regulatory safety standards.
• Collaborate with engineering, design, electrical, and software teams to gather data.
• Organize internal servers and document management systems.
• Participate in supplier technical evaluations.
• SAP usage for project structure, budgeting, and material issuance.
• Review assembly protocols and FAT documents.
• Coordinate with stakeholders for machine readiness.
• Prepare the URS trackability document.
• Mechanically verify machines per drawings.
• Support site engineering during installation and qualification.
• Willing to travel on site if required.

Skills

Project engineering

Documentation management

Cross-functional collaboration

Tools

SAP

Job description

GEA Group seeks a project engineer to oversee multiple engineering projects from design to delivery. You will coordinate cross-functional teams, ensure quality, cost control and schedule adherence, and support on-site installation and qualification activities.

A strong background in machine manufacturing and pharma-related equipment is essential, with willingness to travel as needed. Responsibilities include preparing design qualification packs, reviewing BOMs and drawings, and maintaining