Automation SME – Project Engineer

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. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

ABOUT THE ROLE

The Automation SME – Project Engineer is accountable for technical leadership and project coordination of assigned Automation/IT capital projects. Execution activities may be performed directly by the resource or through oversight and coordination of contractors and system integrators. As a candidate, your company must meet BMS policies, guidelines, and other requirements.

2.1. Capital Project Execution

• Lead the development, planning, and execution of Automation/IT/Network Capital Projects.
• Act as the technical project lead for Automation/IT scope, coordinating engineering, quality, validation, IT, and vendors through all project phases.
• Define project scope, schedules, cost estimates, risks, and deliverables.
• Provide routine project status reporting, milestone tracking, and risk mitigation plans.
• Resolve complex technical and design issues arising during project execution, construction, and start‑up, ensuring decisions support regulatory compliance, safety, product quality, cost, and schedule objectives.
• Provide clear and timely communication on Project Engineering activities, risks, and milestones to internal stakeholders and management. Support Capital Appropriation Requests (CARs), budgeting, and financial tracking.
• Coordinate project execution activities with EHS to ensure compliance with safety, environmental, and waste‑handling requirements throughout all project phases.
• Review vendor quotations, develop technical specifications, and support procurement activities, including purchase requisitions and technical evaluation of equipment and services for Automation/IT capital projects.

2.2. Automation and Systems Engineering

• Lead and/or support the design, specification, procurement, installation, commissioning, and start-up of automation and computerized systems.
• Provide SME support for systems including, but not limited to:
• PLCs, HMI, SCADA, DCS/BAS o DeltaV, Rockwell Automation, FactoryTalk, Siemens, Wonderware o MES systems (e.g., Syncade), data historians (OSI PI), databases (MS SQL), and virtualization platforms
• Review and approve automation architectures, network designs, and system configurations.
• Identify and promote best available automation technologies to meet site and corporate needs. 2.3. Compliance, Quality, and Validation
• Ensure all project activities comply with: o cGMP, FDA, EMA, OSHA, EPA/EQB o 21 CFR Part 11, Engineering, IT, and Security standards
• Support execution of the Computer System Validation (CSV) lifecycle, including requirements, specifications, testing, and qualification.
• Support Performance Qualification (PQ) of equipment and systems installed under capital projects.
• Participate in quality events, including deviations, investigations, CAPAs, internal audits, and regulatory inspections related to automation systems.
• Ensure Automation and computerized systems are delivered in a validated state, in compliance with CSV requirements.
• Support preparation, review, and execution of validation documentation.

2.4. Contractor and Vendor Management

• Manage and coordinate external contractors, system integrators, and vendors.
• Ensure contractor compliance with safety, environmental, security, and quality requirements.
• Review technical proposals, quotations, and specifications.
• Coordinate FAT, SAT, commissioning, and start‑up activities with vendors and internal stakeholders.
• Ensure quality of construction, installation, and system implementation activities for Automation and related infrastructure in accordance with approved designs, specifications, and GMP requirements.

2.5. Documentation and Change Control

• Develop, review, and maintain technical and project documentation, including:
• URS, FRS, DS, and configuration documents.
• SOPs (Operations, Maintenance, Security, Backup/Restore, Disaster Recovery).
• Execute and support change control activities related to automation and computerized systems.
• Ensure proper documentation control, traceability, and data integrity.

2.6. Cross‑Functional Collaboration

• Serve as the Automation Project SME for Manufacturing Business Units.
• Collaborate with Manufacturing, Quality, Engineering, Maintenance, IT, EHS, Purchasing, and Corporate teams.
• Provide technical guidance to resolve complex operational and project-related issues.
• Support client initiatives by ensuring adherence to Project Management processes and governance.

REQUIREMENTS & QUALIFICATIONS

Required

The assigned resource must meet the following minimum 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, of which: o At least four (4) years must be in process automation within a pharmaceutical environment o At least two (2) years must be in computerized systems validation (CSV).
• Demonstrated proficiency in computer system lifecycle concepts, change control processes, and FDA regulatory requirements, including 21 CFR Part 11.
• Proven experience developing and reviewing Computerized Functional Requirements (CFR/URS) and Design Specifications (DS/FRS).
• In-depth knowledge of the design, installation, commissioning, and qualification of computerized systems, PLCs, and automation platforms in pharmaceutical manufacturing.
• Broad knowledge of cGMPs, FDA, EMA, and applicable regulatory guidelines for biopharmaceutical manufacturing facilities.
• Experience supporting internal and external regulatory audits (e.g., FDA, EMA). Strong understanding of pharmaceutical manufacturing processes, equipment, and automation systems.
• Knowledge of electrical controls theory, mechanical concepts, and electronic circuitry, with ability to read and interpret electrical and mechanical drawings.
• Proven skills in project management, systems development, and implementation of manufacturing automation, MES, and quality-related systems.
• Experience with PLC programming platforms, data acquisition systems, historians (e.g., OSI PI), databases (e.g., MS SQL), and industrial networking infrastructures.
• Ability to review and support development of SOPs and work instructions.
• Strong analytical and problem-solving skills, with ability to resolve complex technical issues based on data.
• Fully bilingual English/Spanish, written and verbal.
• Strong interpersonal skills with ability to work effectively across all organizational levels and disciplines.
• Ability to manage and prioritize multiple complex activities simultaneously.
• Self‑starter, well organized, flexible, and able to meet deadlines.
• Willingness to work irregular hours, weekends, and holidays as required.
• Ability to exercise good judgment.

Preferred

• Experience with CMMS systems (e.g., Maximo).
• High level of expertise in Rockwell Automation platforms.
• Experience with Siemens, Wonderware, and FactoryTalk Batch.
• Experience with virtualization platforms (VMware vSphere).
• Experience with MES systems (e.g., Syncade).
• Experience with OSIsoft / AVEVA PI systems and Microsoft SQL databases.

SKILLS

Technical Skills

• PLCs, HMI, SCADA, DeltaV, FactoryTalk — advanced configuration and troubleshooting
• MES systems — support and integration
• Change control execution and CAPA support in regulated environments
• Automation procedure development — SOPs, security plans, backup/restore, disaster recovery
• cGMP, 21 CFR Part 11, and Data Integrity compliance
• Quality event investigation and internal audit support
• Network configuration and industrial communication protocols
• Microsoft Office 365

Soft Skills

• Deep technical ownership of automation systems
• Clear communication with Manufacturing, Quality, IT, and Engineering teams
• Proactive risk identification and escalation
• Disciplined in regulatory documentation and change management
• Project milestone accountability
• Consulting mindset — advising on technology use and process improvement