SUMMARY:
Senior Automation Engineer with extensive experience in the biopharmaceutical industry, specializing in the design, programming, integration, and lifecycle management of manufacturing automation systems, process control platforms, and field instrumentation. Experienced in providing technical automation support for capital projects, system upgrades, equipment integration, and technology implementations within highly regulated GMP environments. Applies advanced automation engineering principles to optimize manufacturing processes, support project execution, and ensure system reliability. Demonstrates strong analytical and troubleshooting capabilities to develop and implement complex automation solutions. Recognized as a subject-matter expert in industrial automation and process control systems and as a key contributor to cross-functional project teams.

FUNCTIONS:

1. Provide senior-level automation engineering support for capital projects, equipment installations, system upgrades, and technology implementations.
2. Collaborate with Project Managers to support the planning, design, execution, and completion of automation deliverables within project timelines and budgets.
3. Design, develop, configure, and implement automation and process control systems using PLC, DCS, HMI, and SCADA platforms.
4. Support automation integration for new manufacturing equipment, process systems, and facility expansions.
5. Participate in project activities including design reviews, FAT/SAT coordination, commissioning, qualification, and startup support.
6. Develop and implement automation strategies to improve process control, equipment performance, and manufacturing efficiency.
7. Provide troubleshooting and technical support for complex automation and control system issues impacting manufacturing operations.
8. Collaborate with cross-functional teams including Manufacturing, Process Engineering, Utilities, Facilities, QA, and Validation to support project execution and operational improvements.
9. Coordinate automation vendors, system integrators, and external engineering firms to ensure successful implementation of automation solutions.
10. Prepare and review technical documentation including User Requirement Specifications (URS), Functional Specifications (FS), Design Specifications (DS), SOPs, and automation configuration documents.
11. Ensure automation systems comply with GMP regulations, SDLC requirements, GAMP 5 guidelines, data integrity standards, and 21 CFR Part 11.
12. Support system commissioning and qualification activities (IQ/OQ/PQ) for new or modified automation systems.
13. Lead or support root cause investigations and technical troubleshooting related to automation systems, instrumentation, and process control.
14. Provide technical expertise during technology transfers, process changes, and new product introductions.
15. Monitor automation system performance and implement improvements to enhance reliability, efficiency, and compliance.
16. Maintain strong communication with project teams and operational stakeholders to ensure alignment and project success.

EDUCATION AND EXPERIENCE REQUIEREMENTS:

• Bachelor’s or Master’s degree in Engineering with 8+ years of experience in the Pharmaceutical or Biotechnology industries.

PREFERRED QUALIFICATIONS:

• Experience supporting automation scope within capital projects in GMP manufacturing environments.
• Hands-on experience with Rockwell (Allen-Bradley), Siemens, or other distributed control systems.
• Experience supporting equipment integration, automation upgrades, and facility expansions.
• Strong understanding of automation system validation and lifecycle management.
• Experience supporting commissioning, qualification, and startup activities.

SKILLS:

• Strong expertise in PLC, DCS, HMI, and SCADA automation systems.
• Advanced troubleshooting and analytical problem-solving capabilities.
• Knowledge of GMP, SDLC, GAMP 5, data integrity, and 21 CFR Part 11.
• Experience coordinating cross-functional project teams, vendors, and system integrators.
• Strong documentation, communication, and project coordination skills.
• Ability to support engineering projects from design through commissioning and operational handover.

WORK METHODOLOGY:

• Full time job
• Client industry: Biopharmaceutical
• Full on site job in Caguas, PR (hybrid or remote work arrangement for a limited period).
• 1 year of contract term with expectation of continuity based on performance and budget
• Administrative shift. Weekends and overtime may also be required.