Senior Automation Project Engineer
HybridManatí, Manatí, Puerto Rico
Job Summary
Lead planning, development, and execution of Automation, IT, and Network Capital Projects through the organization's Stage Gate process from initial design to closeout. Define scope, schedules, budgets, and risks while coordinating activities across Engineering, Quality, Validation, IT, Manufacturing, EHS, contractors, and vendors. Manage procurement, vendor proposals, and technical evaluations to ensure projects meet regulatory compliance, safety, product quality, and cost objectives. Support Computer System Validation lifecycles, FAT/SAT activities, and data integrity standards while resolving complex technical issues in PLC, SCADA, and MES systems. Prepare status reports, financial tracking, and risk mitigation plans for cross-functional stakeholders.
Required 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
- Experience developing or reviewing URS, FRS, DS, CFR, and other automation lifecycle documents
- Experience with the design, installation, commissioning, start-up, and qualification of computerized and automation systems
- Knowledge of PLCs, industrial control systems, manufacturing automation, MES, databases, historians, and industrial networking
- Working knowledge of cGMP, FDA, EMA, and applicable pharmaceutical manufacturing regulations
- Experience supporting internal audits, customer audits, or regulatory inspections
- Understanding of pharmaceutical manufacturing processes, equipment, and automation applications
- Knowledge of electrical controls, mechanical concepts, and electronic circuitry
- Ability to read and interpret electrical, mechanical, control, and system drawings
- Strong analytical, organizational, troubleshooting, and problem-solving skills
- Ability to manage multiple complex projects and priorities simultaneously
- Strong written and verbal communication skills
- Fully bilingual in English and Spanish
- Ability to work effectively with employees, contractors, vendors, and leadership across different organizational levels
- Must be available to work on-site or remotely according to project requirements
- Must be available for occasional evenings, weekends, holidays, shutdowns, or after-hours project activities
- Must be able to complete all required site training and maintain training requirements in good standing
- Must be comfortable managing contractors, coordinating cross-functional teams, resolving complex technical issues, and operating within a highly regulated pharmaceutical manufacturing environment
Desired Qualifications
- Experience with Rockwell Automation platforms
- Experience with FactoryTalk Batch
- Experience with Siemens and Wonderware systems
- Experience with DeltaV control systems
- Experience with Syncade or other Manufacturing Execution Systems
- Experience with OSIsoft or AVEVA PI data historians
- Experience with Microsoft SQL databases
- Experience with VMware vSphere or similar virtualization platforms
- Experience with CMMS platforms such as Maximo
- Previous experience managing Automation, IT, Network, or capital improvement projects in an FDA-regulated facility
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