Automation SME – Project Engineer

JC Automation Corp•Manatí, PR

About The Position

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. 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. 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, DeltaV, Rockwell Automation, FactoryTalk, Siemens, Wonderware, 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. Compliance, Quality, and Validation: Ensure all project activities comply with: cGMP, FDA, EMA, OSHA, EPA/EQB, 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. 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. 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. 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

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: At least four (4) years must be in process automation within a pharmaceutical environment, 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.

Nice To Haves

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.

Responsibilities

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.
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, DeltaV, Rockwell Automation, FactoryTalk, Siemens, Wonderware, 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.
Ensure all project activities comply with: cGMP, FDA, EMA, OSHA, EPA/EQB, 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.
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.
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.
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.