Senior Automation Engineer, MES

Johnson & Johnson•Anasco, PR

1d•Onsite

About The Position

The Senior Automation Engineer, MES is an experienced individual contributor responsible for supporting validated automation and manufacturing systems in regulated environments. This role focuses on Computer System Validation (CSV) activities involving PLC, SCADA, Data Historian, Manufacturing Execution Systems (MES), and Operational Technology (OT) infrastructure while leveraging automation and controls expertise as an enabling discipline. The position supports the full lifecycle of computerized systems, including requirements definition, risk assessments, validation, change control, and system retirement. The engineer partners closely with Quality, IT, Manufacturing, Laboratory, and Engineering teams to ensure compliant, reliable, and sustainable automation solutions supporting production, laboratory operations, and data integrity requirements. The role contributes to KPI achievement, modernization initiatives, and new product introductions while mentoring junior engineers and applying Johnson & Johnson’s Credo and Leadership Imperatives.

Requirements

Bachelor’s degree in engineering (Chemical, Automation, Electrical, Controls, Computer Science, or related discipline).
Minimum 2+ years of experience supporting automated systems in regulated manufacturing environments (pharmaceutical, medical device, or life sciences preferred).
Hands‑on experience supporting CSV for automation and manufacturing systems.
Working knowledge of PLC and SCADA platforms (Allen‑Bradley, Siemens, Beckhoff, or equivalent).
Experience supporting or integrating: MES systems, Data Historian platforms, Laboratory or manufacturing equipment interfaces.
Understanding of system modeling, automation architectures, and data flows.
Familiarity with OT infrastructure components and industrial networking concepts.
Deep understanding of cGMP regulations and FDA requirements for automated systems.
Experience with qualification protocols (IQ/OQ/PQ) and validation documentation.
Working knowledge of: 21 CFR Part 11 (Electronic Records and Signatures), GAMP 5 principles.
ISO 13485 / ISO 9001 (preferred).
Experience with change control and deviation management in regulated environments.
Strong technical writing capabilities for SOP development and system documentation.
Excellent communication skills for conducting design reviews and customer meetings.
Experience developing testing protocols and preventive maintenance programs.
Ability to work effectively in fast-paced, regulated manufacturing environments.
Strong analytical and systematic problem-solving approach.
Flexibility to support production operations including off-hours support.

Nice To Haves

Direct experience working with validated MES platforms.
Exposure to Industry 4.0 or digital manufacturing initiatives.
Experience with system redundancy, backups, and disaster recovery planning.
Automation or validation certifications (Rockwell, Siemens, Beckhoff, or equivalent).
Experience with Industry 4.0 initiatives and digital transformation projects.
Cloud-based automation solutions and data analytics platforms.
Advanced process analytics and machine learning applications.
Experience with backup systems, redundancy configurations, and disaster recovery planning.
Knowledge integrating Artificial Intelligence in manufacturing processes to enhance manual operations and improve efficiency.

Responsibilities

Support automated control systems including PLCs, SCADA, Data Historian, and integrated equipment within validated manufacturing and laboratory environments.
Participate in the design, review, and support of automation solutions ensuring alignment with validation, data integrity, and regulatory requirements.
Support automation system modeling, architecture definition, and documentation to enable compliant system implementation and sustainment.
Collaborate with controls engineers and system integrators on automation changes, upgrades, and modernization initiatives.
Support troubleshooting of automation systems while ensuring deviations and corrective actions are managed through formal quality processes.
Execute and support CSV activities across automation and manufacturing systems, including PLC, SCADA, Data Historian, MES, laboratory integrations, and OT infrastructure.
Support the full system lifecycle: User & Functional Requirements, Risk Assessments, Validation Plans & Protocols (IQ/OQ/PQ), Validation Reports, Periodic Reviews, Change Control, System Retirement.
Coordinate document reviews, approvals, and validation deliverables with Quality, IT, and business stakeholders.
Ensure validation activities follow risk‑based approaches aligned with GAMP 5 and internal quality standards.
Support validation readiness during audits, inspections, and internal quality reviews.
Support integration of manufacturing and laboratory equipment with MES platforms, ensuring compliant data exchange and traceability.
Participate in configuration, validation, and maintenance of: MES interfaces, Equipment integration layers, Data Historian systems.
Ensure accurate, secure, and compliant data collection in support of: Electronic Records, Process monitoring, Reporting and analytics.
Support Part 11 controls related to audit trails, access management, electronic records, and signatures.
Diagnose and resolve complex technical issues involving both software and hardware components of automated equipment.
Participate in solving efforts for critical production systems and implement preventive maintenance strategies.
Provide on-call support for production operations as needed.
Handle system integrations across diverse platforms including Beckhoff, Allen‑Bradley, Siemens, Wonderware, and data historian systems.
Support setup, documentation, and validation of OT infrastructure, including: Servers and virtual environments, Industrial networks, Automation system architectures.
Participate in infrastructure risk assessments, change evaluations, and re‑validation activities.
Ensure OT systems align with cybersecurity, backup, disaster recovery, and operational sustainability requirements.
Work closely with Quality, IT, Manufacturing, Laboratory, and Engineering teams to support compliant system operations.
Participate in vendor meetings, FAT/SAT activities, and technical design reviews.
Author and maintain SOPs, work instructions, validation documentation, and system lifecycle artifacts.
Provide guidance and mentorship to junior engineers on CSV, automation documentation, and validation best practices.
Apply Microsoft Project for comprehensive project planning, resource allocation and timeline management.
Participate in technical design reviews and vendor management meetings with equipment suppliers and service providers.
Prepare detailed Standard Operating Procedures (SOPs), work instructions, and user documentation.
Manage Computer System Validation (CSV) processes and system lifecycle documentation throughout project phases.