Senior Automation Engineer, MES

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Purpose: 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 & Johnsons Credo and Leadership Imperatives.

You will be responsible for:

Automation & Controls Systems Support

• 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.

Computer System Validation (CSV) & Lifecycle Management

• 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 riskbased approaches aligned with GAMP 5 and internal quality standards.

• Support validation readiness during audits inspections and internal quality reviews.

MES Data Historian & Laboratory Integration

• 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.

Technical Problem Resolution & System Integration

• 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

OT Infrastructure Setup & Validation

• 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 revalidation activities.

• Ensure OT systems align with cybersecurity backup disaster recovery and operational sustainability requirements.

CrossFunctional Collaboration & Support

• 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.

Multi-functional Collaboration

• 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

Qualifications / Requirements:

Experience & Education

• Bachelors 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).

• Handson experience supporting CSV for automation and manufacturing systems.

Core Technical Expertise

• Working knowledge of PLC and SCADA platforms (AllenBradley 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.

Regulatory & Compliance Knowledge

• 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.

Communication Skills

• Strong technical writing capabilities for SOP development and system documentation

• Excellent communication skills for conducting design reviews and customer meetings

Additional Requirements

• 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

Preferred Qualifications

Advanced Technical Skills

• 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).

Emerging Technologies

• 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.

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