Automation Project Engineer - Pharma Manufacturing

FITS, LLC; Manatí (PR); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

FITS, LLC is seeking an experienced Automation Project Engineer for Capital Project initiatives in the pharmaceutical sector. You will manage automation deliverables, coordinate with vendors, and ensure compliance with cGMP and regulatory requirements.

Responsibilities include leading project planning, commissioning, and qualification activities, plus collaboration with Quality, Validation, IT, and Manufacturing teams. Bilingual Spanish/English is preferred; on-site role in Puerto Rico.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Information Systems, or related field.

Responsabilités

• Check in with vendors, contractors, and system integrators on active automation/IT projects.
• Troubleshoot technical issues during installation, start-up, or qualification activities.
• Monitor project schedules and flag risks or delays to stakeholders.
• Coordinate with EHS, Quality, and Manufacturing on day-to-day project matters.
• Prepare and present weekly project status reports (milestones, budget, risks).
• Attend cross-functional meetings with Engineering, Quality, Validation, IT, and Manufacturing.
• Review vendor quotes and update technical documentation (URS, FRS, DS) as designs evolve.
• Move through project phases — planning and design, procurement, execution/construction, commissioning and qualification (FAT/SAT, CSV, PQ), and close-out.
• Support audits, deviations, and CAPAs as needed.
• Occasionally work irregular hours during critical milestones (start-up, cutover, audits)

Description du poste

FITS, LLC is seeking an experienced Automation Project Engineer for Capital Project initiatives in the pharmaceutical sector. You will manage automation deliverables, coordinate with vendors, and ensure compliance with cGMP and regulatory requirements.

Responsibilities include leading project planning, commissioning, and qualification activities, plus collaboration with Quality, Validation, IT, and Manufacturing teams. Bilingual Spanish/English is preferred; on-site role in Puerto Rico.