Senior Commissioning Engineer

QRC Group•Manati, PR

1d•Onsite

About The Position

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 that combines facility and utility commissioning with automation and Building Automation System verification, both of which concentrate in the same installation and startup window.

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.

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.