Senior Commissioning Engineer

We are seeking a Senior Commissioning Engineer to execute the field commissioning of the utility, HVAC, electrical, instrumentation and automation systems serving a new GMP production autoclave at Manatí, Puerto Rico.

This is a multi-discipline position. It combines facility and utility commissioning with automation and Building Automation System verification, both of which concentrate in the same installation and startup window.

Key Responsibilities

● Perform receipt verification and mechanical completion verification for equipment and systems within the commissioning boundary.

● Conduct drawing walkdowns and issue Drawing Walkdown Verification Reports.

● Execute instrument loop checks and point-to-point verification and issue the corresponding reports.

● Perform utility startup verification and author the commissioning reports for clean steam, condensate return, plant steam, potable water and compressed air systems.

● Support HVAC commissioning, including HEPA filtration systems, room differential pressure verification and environmental monitoring interfaces.

● Review and accept the Testing, Adjusting and Balancing report issued by the mechanical contractor.

● Perform electrical systems checkout and author the report.

● Support Honeywell Experion integration and verify Building Automation System interfaces.

● Execute or witness the Building Automation System integration test and author the report.

● Perform alarm and interlock verification and verify the sequence of operations, authoring the corresponding reports.

● Verify data collection interfaces and network interfaces required for equipment integration.

● Conduct field inspections and quality assessments during the construction phase and develop punch list items.

● Support vendor startup activities and functional testing, and participate in integrated systems testing.

● Prepare assigned commissioning protocols and reports and route them through the client document management and digital validation systems.

Requirements

● Bachelor's degree in Mechanical, Electrical, Chemical or Automation Engineering, or a technical degree with equivalent field experience.

● Minimum five (5) years of experience in facilities and utilities commissioning within pharmaceutical or medical device manufacturing.

● Prior Commissioning and Qualification experience.

● Background in a pharmaceutical products manufacturing environment, specifically in a sterile packaging area.

● Demonstrated clean utility commissioning experience, with clean steam required.

● HVAC commissioning experience including HEPA filtration interfaces and room pressurization verification.

● Demonstrated Honeywell Experion and/or Building Automation System commissioning experience. This requirement is mandatory and is not substitutable.

● Fully bilingual in Spanish and English, written and verbal, with strong technical writing skills in English.

● Experience in alarm and interlock testing and sequence of operations verification.

● Construction turnover experience in an operating GMP facility.

● Strong working knowledge of cGMP regulations.

● Demonstrated experience with digital validation solutions (ALM) and with the client document management system.