Automation Project Lead - Pharma Systems & Compliance

JC Automation; Manatí (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

JC Automation Corp. is seeking an Automation SME – Project Engineer to lead capital automation/IT projects, coordinating engineering, validation, IT, and vendors through all phases to ensure regulatory compliance, safety, and product quality.

The role requires 5+ years in pharma operations, with 4+ in process automation and 2+ in CSV, plus bilingual English/Spanish. The successful candidate will drive project scope, schedules, risk management, and documentation, while interfacing with

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Information Systems, or related field.
• Minimum five (5) years of experience in pharmaceutical operations or manufacturing environments with proven project management experience.
• At least four (4) years in process automation within a pharmaceutical environment.
• At least two (2) years in computerized systems validation (CSV).
• Proven experience in FDA regulatory requirements, including 21 CFR Part 11.
• Experience with CFR/URS and DS/FRS development, automation platforms, and MES/PI systems.

Responsibilities

• Lead the development, planning, and execution of Automation/IT capital projects.
• Coordinate engineering, quality, validation, IT, and vendors through all project phases.
• Define scope, schedules, costs, risks, and deliverables; provide status reporting.
• Ensure safety, quality, compliance, and regulatory alignment across projects.
• Review vendor quotes, support procurement, and manage change control.
• Collaborate with cross-functional teams including EHS, IT, and Manufacturing.

Job description

JC Automation Corp. is seeking an Automation SME – Project Engineer to lead capital automation/IT projects, coordinating engineering, validation, IT, and vendors through all phases to ensure regulatory compliance, safety, and product quality.

The role requires 5+ years in pharma operations, with 4+ in process automation and 2+ in CSV, plus bilingual English/Spanish. The successful candidate will drive project scope, schedules, risk management, and documentation, while interfacing with