Pharma Manufacturing Project Engineer – GMP & Startup

Pinnaql, Inc.; Juncos (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Project Engineer to support capital projects within regulated pharma/biotech environments.

You will coordinate engineering activities across planning, installation, commissioning, and handover, ensuring technical excellence and regulatory compliance. You will work with Engineering, Operations, Quality, EHSS, Procurement, and contractors to deliver safe, on-time project outcomes in Puerto Rico.

Qualifications

• Minimum of 3 years supporting capital projects in FDA-regulated industries.
• Experience with manufacturing systems, packaging equipment, facilities, utilities, or cleanroom environments.
• Experience delivering engineering projects through design, procurement, installation, startup, commissioning, or handover.
• Familiarity with GMP documentation, change management, and project execution practices.
• Experience coordinating with contractors, vendors, and cross-functional technical teams.
• Familiarity with commissioning/startup activities and operational readiness.
• Experience with engineering and project coordination tools such as AutoCAD, SAP, MS Project, Bluebeam, or similar systems is preferred.
• Excellent verbal and written communication in English and Spanish.

Responsibilities

• Support engineering and technical execution activities throughout the project lifecycle from planning through startup and handover.
• Coordinate engineering deliverables, technical reviews, design changes, and project implementation activities.
• Support development and review of engineering documentation including technical specifications, drawings, calculations, change requests, project records, and turnover documentation.
• Coordinate with equipment vendors, contractors, engineering firms, and internal stakeholders to support project execution.
• Support installation activities, field coordination, startup readiness, commissioning support, and punch-list resolution.
• Participate in project meetings and provide technical updates, action item follow-up, risk identification, and status reporting.
• Assist with project planning, scheduling, procurement coordination, and tracking of technical deliverables.
• Support troubleshooting and resolution of technical issues impacting project execution, commissioning activities, or operational readiness.
• Support equipment startup, turnover, and field implementation activities as required.
• Support execution of engineering activities in accordance with applicable GMP, safety, environmental, and site requirements.

Skills

Engineering coordination

Cross-functional collaboration

Problem-solving

Technical writing

English language

Spanish language

Tools

AutoCAD

SAP

MS Project

Bluebeam

Job description

Validation & Engineering Group, Inc. seeks a Project Engineer to support capital projects within regulated pharma/biotech environments.

You will coordinate engineering activities across planning, installation, commissioning, and handover, ensuring technical excellence and regulatory compliance. You will work with Engineering, Operations, Quality, EHSS, Procurement, and contractors to deliver safe, on-time project outcomes in Puerto Rico.