Mfg Systems Engineer

hace 4 semanas


Juncos, Puerto Rico Biopharma Consulting Jad Group A tiempo completo

Under general supervision, the Mfg Systems Engineer provides process optimization strategies and troubleshooting support for operational issues within the operations, manufacturing, pilot plant, or capital projects environment on second shift.
The role involves applying basic engineering principles to the design and implementation of system modifications, experiments, and capital projects.
The engineer will analyze results, provide technical solutions to complex problems, and work with various departments to ensure smooth operations and compliance.
Key Responsibilities: Shift and Operational Support: Support non-standard shift operations, including second, night, 12-hour, and/or weekend shifts (24/7 operation).
Maintain prompt and regular attendance to ensure shift requirements are met.
Technical Problem Solving: Provide solutions to a variety of moderate scope technical problems, applying standard engineering techniques and procedures.
Investigate issues that require analysis of limited variables to complete specific objectives.
Troubleshoot and resolve equipment, automation, or process issues in the field.
Engineering Projects & Design: Work with project managers to complete design, engineering, and construction projects within budget and schedule constraints.
Develop process control applications utilizing Programmable Logic Controllers (PLC), Distributed Control Systems (DCS), Human Machine Interfaces (HMI), and SCADA systems.
Work with consultants, architects, and engineering firms to develop standard design documents and specifications.
Generate project cost estimates and schedules for equipment modifications or installations.
System Audits & Compliance: Routinely audit operational performance and regulatory compliance for a moderate number of equipment or systems.
Ensure adherence to industry standards for batch control systems, software development lifecycle methodologies, and regulatory compliance (21 CFR Part 11, GAMP).
Develop and maintain SOPs, engineering documents, and operating standards.
Collaboration & Cross-Functional Support: Work with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and/or Validation departments to develop system modification requirements and recommendations.
Serve as a technical expert for equipment or systems during troubleshooting operations and complex problem resolution.
Technical Documentation & Reporting: Support the creation and execution of validation protocols.
Write basic technical reports and presentations.
Manage and contribute to technical documentation as required.
Specialized Equipment & Technology: Operate specialized laboratory equipment and computer systems as appropriate.
Maintain expertise in automation and control systems, including Rockwell Automation platforms, Allen-Bradley PLCs, FTView SE, and FTBatch systems.
Utilize knowledge of DeviceNet technologies for field instrumentation.
Knowledge & Experience in Drug Substance Operations: Experience with drug substance operations involving mammalian cell culture, protein purification, media and buffer preparation, clean utilities, CIP, SIP, and production services.
Safety & Environmental Compliance: Ensure compliance with Environmental, Health, and Safety (EHS) standards in all engineering and operational activities.
Preferred Experience/Skills: Educational background in Mechanical, Electrical, Process Control, or Chemical Engineering.
Strong verbal communication skills in English and Spanish.
Comprehensive understanding of validation protocol execution requirements.
Knowledge of programming languages (e.g., VBA, SQL) and experience with computer administration (Windows 10/11, Microsoft Server 208-2022).
Hands-on experience in automation, PLC/SCADA programming, and process control systems.
Requirements Qualifications: Master's degree in Engineering, OR Bachelor's degree in Engineering with 2 years of Engineering and/or Automation experience.
Experience with PLC/SCADA systems, particularly Rockwell Automation platforms, Allen-Bradley PLCs, and FTView SE.
Familiarity with pharmaceutical/biotech processes and validation practices.
Experience in batch processing using ASTM 2500, ISA S88, and S95 techniques.
Benefits Non-Standard Shift Flexibility to work non-standard shifts, including second, night, 12-hour, and/or weekend shifts.



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