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Manufacturing Systems Engineer 2997342

Title: Manufacturing Systems Engineer

Location: Juncos, PR (Open to Puerto Rico residents)

Work Arrangement: 100% Onsite, 12-hour shifts (Day Shift) with availability for non-standard shifts as needed.

Positions: 1

Period: Approximately 10 months.


SUMMARY

Under general supervision, the Manufacturing Systems Engineer provides characterization of process optimization strategies and troubleshooting of operational issues within manufacturing, pilot plant, or capital projects environments. This role applies fundamental engineering principles to the design and implementation of system modifications, experiments, and capital projects while analyzing and presenting interpretations of results for operational issues or engineering projects of minor scope and complexity.


RESPONSIBILITIES

  • Support non-standard shift operations, including first, second, night, 12-hour, and/or weekend shifts (24/7 operations).
  • Provide solutions to technical problems of moderate scope and complexity.
  • Evaluate, select, and apply standard engineering techniques and procedures under general supervision.
  • Perform assignments with clear objectives that require investigating a limited number of variables.
  • Initiate and complete routine technical tasks.
  • Ensure prompt and regular attendance in the workplace.
  • Serve as a technical expert in troubleshooting operations for equipment and systems.
  • Audit operational performance and regulatory compliance of moderate to complex equipment and systems.
  • Collaborate with departments including Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation to develop system modification requirements and recommendations.
  • Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
  • Engage with consultants, architects, and engineering firms to develop standard design documents.
  • Obtain and assess quotes for equipment modifications or installations.
  • Generate project cost estimates and schedules.
  • Develop process control applications using Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human-Machine Interfaces (HMI), and Supervisory Control and Data Acquisition (SCADA) systems.
  • Maintain familiarity with industry standards for batch control systems, software development life cycle methodologies, 21 CFR Part 11 compliance, and GAMP.
  • Develop specifications, engineering documents, Standard Operating Procedures (SOPs), and operating standards.
  • Troubleshoot and resolve equipment, automation, or process issues in the field.
  • Operate specialized laboratory equipment and computers as required.


EDUCATION & EXPERIENCE REQUIREMENTS

  • Master’s degree in Engineering OR
  • Bachelor’s degree in Engineering with 2+ years of experience in Engineering and/or Automation.


PREFERRED QUALIFICATIONS

  • Hands-on experience with Automation, PLC, and SCADA systems.
  • PLC/SCADA programming expertise.
  • Basic knowledge of Computer Administration (Windows 10/11, Microsoft Server 2008–2022).
  • Educational background in Mechanical, Electrical, Process Control, or Chemical Engineering.
  • Experience in programming, designing, installing, and managing manufacturing process controls, automation, and field instrumentation technologies.
  • Working knowledge of pharmaceutical/biotech processes.
  • Familiarity with validation processes and documentation within highly regulated environments.
  • Strong verbal communication skills in English and Spanish.
  • Comprehensive understanding of validation protocol execution requirements.
  • Proficiency in:
  • Problem-solving and applied engineering
  • Technical report writing and presentations
  • Personal organization
  • Validation protocol writing
  • Managing change
  • Equipment-specific technical knowledge
  • Analytical problem-solving
  • Computer literacy
  • Expertise in Rockwell Automation Platform and Allen-Bradley PLCs, including:
  • Rockwell Automation Factory Talk & ControlLogix PLC Platform
  • Rockwell SLC500 PLC families Controllers
  • Rockwell Automation FTView SE and FTBatch systems
  • DeviceNet technologies
  • Experience in Drug Substance Operations involving Mammalian Cell Culture, Protein Purification, Media and Buffer Preparation, Clean Utilities, CIP, SIP, and Production Services.
  • Ability to work flexible schedules to support 24/7 operations.
  • Knowledge of ASTM 2500, ISA S88, and S95 techniques (Batch Processing experience is an advantage).
  • Programming experience in VBA and SQL database programming.


If you meet the qualifications and are interested in this opportunity, please apply inside the job description with your updated resume.



Thank you. We will be in contact soon.

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