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Position Overview

Our client, a leading pharmaceutical manufacturing organization, is seeking an experienced Automation Subject Matter Expert (SME) / Project Engineer to lead and support Automation, Information Technology, and Network Capital Projects at its Manati facility.

This position will provide technical leadership and project coordination throughout the complete capital project lifecycle, from initial planning and design through procurement, installation, commissioning, qualification, start-up, and project closeout.

The selected professional will collaborate closely with Manufacturing, Engineering, Quality, Validation, IT, Maintenance, EHS, Purchasing, contractors, system integrators, and equipment vendors to ensure projects are completed safely, on schedule, within budget, and in compliance with applicable regulatory and corporate standards.

Key Responsibilities

Capital Project Management

• Lead the planning, development, and execution of Automation, IT, and Network Capital Projects.
• Manage projects through the organization's established Stage Gate Project Management process.
• Serve as the technical project lead for automation and computerized system scopes.
• Define project scope, schedules, budgets, cost estimates, risks, milestones, and deliverables.
• Coordinate project activities across Engineering, Quality, Validation, IT, Manufacturing, EHS, contractors, and vendors.
• Prepare and communicate routine project status reports, milestone updates, financial tracking, and risk mitigation plans.
• Support Capital Appropriation Requests, project budgeting, procurement activities, and purchase requisitions.
• Review vendor proposals, quotations, equipment specifications, and technical evaluations.
• Identify and resolve complex technical, design, construction, commissioning, and start-up issues.
• Ensure project decisions support regulatory compliance, employee safety, product quality, cost, and schedule objectives.

Automation and Systems Engineering

• Lead or support the design, specification, procurement, installation, commissioning, and start-up of automation and computerized systems.
• Provide technical expertise for systems such as:
  • PLC, HMI, SCADA, DCS, and Building Automation Systems
  • Rockwell Automation and FactoryTalk
  • DeltaV
  • Siemens
  • Wonderware
  • Manufacturing Execution Systems, including Syncade
  • Data historians, including OSIsoft or AVEVA PI
  • Microsoft SQL databases
  • Virtualization platforms
• Review and approve automation architectures, network designs, control strategies, and system configurations.
• Identify and recommend automation technologies that support manufacturing and business requirements.
• Support troubleshooting and resolution of complex automation and computerized system issues.

Compliance, Quality, and Validation

• Ensure project activities comply with applicable requirements, including:
  • Current Good Manufacturing Practices
  • FDA and EMA regulations
  • 21 CFR Part 11
  • OSHA and environmental requirements
  • Data Integrity and Cybersecurity standards
  • Corporate Engineering, IT, Quality, and Security standards
• Support the complete Computer System Validation lifecycle.
• Participate in the preparation, review, and execution of:
  • User Requirements Specifications
  • Functional Requirements Specifications
  • Design Specifications
  • Configuration documentation
  • Testing and qualification protocols
  • FAT and SAT documentation
  • Commissioning and start-up documentation
• Support Performance Qualification activities for equipment and systems installed through capital projects.
• Ensure automation and computerized systems are delivered in a validated and operational state.
• Participate in deviations, investigations, CAPAs, change controls, internal audits, and regulatory inspections related to automation systems.
• Maintain appropriate documentation control, traceability, and data integrity throughout the project lifecycle.

Contractor and Vendor Management

• Manage and coordinate external contractors, system integrators, consultants, and equipment vendors.
• Ensure contractors comply with applicable safety, environmental, quality, cybersecurity, and site requirements.
• Coordinate Factory Acceptance Testing, Site Acceptance Testing, commissioning, qualification, and start-up activities.
• Monitor the quality of construction, installation, programming, and system implementation activities.
• Confirm that completed work meets approved designs, technical specifications, GMP requirements, and project expectations.

Documentation and Cross-Functional Support

• Develop, review, and maintain technical and project documentation.
• Support the development and revision of SOPs and work instructions related to:
  • System operations
  • Maintenance
  • Security
  • Backup and restoration
  • Disaster recovery
• Serve as the Automation Project SME for Manufacturing business units.
• Provide technical guidance to internal stakeholders and project teams.
• Collaborate effectively with Manufacturing, Engineering, Quality, Validation, Maintenance, IT, EHS, Purchasing, and Corporate teams.
• Prepare project closeout documentation and ensure deliverables are completed within the required turnaround times.

Minimum 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.

Preferred 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.

Schedule and Availability

• Regular schedule is Monday through Friday.
• 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.

Ideal Candidate

The ideal candidate is a self-directed and highly organized automation professional who combines strong technical knowledge with effective project management skills. This individual must be comfortable managing contractors, coordinating cross-functional teams, resolving complex technical issues, and operating within a highly regulated pharmaceutical manufacturing environment.