Pharma Automation Project Lead

HR Works, Inc.; Manatí (PR); Hybrid; USD 110,000 - 160,000; Full time

Job summary

HR Works, Inc. seeks an Automation Subject Matter Expert and Project Engineer to lead capital projects at our Manatí facility.

You will oversee automation, IT, and network scopes from design through startup, coordinating with Manufacturing, Engineering, Quality, Validation, and IT to ensure safety, quality, and on-time delivery. The ideal candidate combines hands-on control systems knowledge with strong project management, regulatory experience, and cross-functional collaboration in a highly

Qualifications

• Bachelor’s degree in Engineering or related field.
• 5+ years in pharmaceutical manufacturing or regulated environment.
• Experience in automation lifecycle, validation, and CAPA processes.
• Knowledge of FDA/21 CFR Part 11 regulations.

Responsibilities

• Lead planning and execution of Automation, IT, and Network capital projects.
• Coordinate activities across Engineering, Quality, Validation and IT.
• Support Computer System Validation lifecycle and QA documentation.
• Review vendor proposals, equipment specs, and FAT/SAT activities.
• Ensure regulatory compliance, safety, quality, and schedule objectives.
• Manage external contractors and system integrators.
• Develop technical documentation and project closeout records.

Skills

Project Management

Automation

Cross-functional leadership

Regulatory compliance

Electrical controls

Bilingual English/Spanish

Vendor coordination

Education

Bachelor’s degree in Engineering or related field

Tools

Rockwell Automation

FactoryTalk

DeltaV

Siemens

Wonderware

Syncade

OSIsoft PI

AVEVA PI

Microsoft SQL

VMware vSphere

Maximo

Job description

HR Works, Inc. seeks an Automation Subject Matter Expert and Project Engineer to lead capital projects at our Manatí facility.

You will oversee automation, IT, and network scopes from design through startup, coordinating with Manufacturing, Engineering, Quality, Validation, and IT to ensure safety, quality, and on-time delivery. The ideal candidate combines hands-on control systems knowledge with strong project management, regulatory experience, and cross-functional collaboration in a highly