Lead Automation & IT Capital Projects

HR Works; Manatí (PR); On-site; USD 110,000 - 170,000; Full time

Job summary

Not disclosed is seeking an Automation Subject Matter Expert (SME) / Project Engineer to lead capital projects at its Manatí facility. The role spans automation, IT, and network projects from planning to commissioning while coordinating with cross-functional teams to ensure safety, quality, and regulatory compliance.

The successful candidate will have extensive pharma-automation experience, knowledge of cGMP, FDA 21 CFR Part 11, and a proven track record in steering complex projects in a

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Information Systems, Automation, or a related technical field.
• Minimum of five years of experience within pharmaceutical manufacturing, life sciences, or another highly regulated manufacturing environment.
• At least four years of experience in process automation within a pharmaceutical environment.
• At least two years of experience supporting Computer System Validation.
• Proven project management experience involving automation, computerized systems, IT infrastructure, or capital projects.
• Strong knowledge of the computerized system lifecycle, change control, data integrity, and validation requirements.
• Demonstrated knowledge of FDA regulations and 21 CFR Part 11.

Responsibilities

• Lead automation, IT, and network capital projects across the lifecycle.
• Define project scope, schedules, budgets, risks, milestones, and deliverables.
• Coordinate activities across Engineering, Quality, Validation, IT, Manufacturing, EHS, contractors, and vendors.
• Ensure regulatory compliance and data integrity throughout projects.
• Manage external contractors and system integrators; oversee testing and start-up.
• Prepare project status reports, budgeting, procurement, and risk mitigation plans.

Skills

Project management

Cross-functional collaboration

Analytical skills

Communication skills

Regulatory understanding

Education

Bachelor’s degree in Engineering, Computer Science, Information Systems, Automation, or related field

Tools

Rockwell Automation

FactoryTalk

DeltaV

Siemens

Wonderware

OSIsoft/AVEVA PI

Microsoft SQL databases

VMware vSphere

Job description

Not disclosed is seeking an Automation Subject Matter Expert (SME) / Project Engineer to lead capital projects at its Manatí facility. The role spans automation, IT, and network projects from planning to commissioning while coordinating with cross-functional teams to ensure safety, quality, and regulatory compliance.

The successful candidate will have extensive pharma-automation experience, knowledge of cGMP, FDA 21 CFR Part 11, and a proven track record in steering complex projects in a