Commissioning Lead-Construction & Facility Systems

We are seeking a Commissioning Lead to direct the commissioning of construction and facility systems supporting the installation of a new GMP production autoclave in a sterile packaging manufacturing area at Manatí, Puerto Rico.

The position owns commissioning planning, documentation control and the system turnover process from design review through operational readiness and final handover, coordinating with construction contractors, equipment suppliers and site functions including Engineering, Manufacturing, Maintenance, Facilities, Automation, Validation, Quality Assurance and EHS.

● Review the design package and participate in design reviews.

● Develop the Commissioning Execution Plan, the system boundary definition package and the system-based Level 3 commissioning schedule.

● Define the responsibility matrix for protocol development, execution, witnessing and approval across QRC, contractors and equipment suppliers.

● Develop and maintain the Turnover Package index and support the Care, Custody and Control transfer process.

● Manage the deficiency and punch list log and drive closure with contractors and vendors.

● Author commissioning protocols and reports and route all deliverables through the client document management and digital validation systems.

● Coordinate execution with mechanical, electrical and controls contractors and with the equipment supplier.

● Lead System Turnover Readiness Assessments and the Operational Readiness Walkdown.

● Prepare the Pre-Startup Safety Review support package and support its execution.

● Verify training readiness and maintenance readiness prior to handover to Operations.

● Issue the weekly progress report and participate in project meetings.

● Assemble the Final Turnover Package and Handover Report and the Final Commissioning Summary Report.

● Support electronic change control closure.

Requirements

 ● Bachelor's degree in Mechanical, Chemical, Electrical or Industrial Engineering, or equivalent technical education with commensurate experience.

● Minimum eight (8) years in commissioning and qualification within pharmaceutical or medical device manufacturing, of which at least five (5) years in facilities and utilities commissioning projects.

● Prior Commissioning and Qualification experience.

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

● Demonstrated experience leading construction turnover and startup on capital projects within an operating GMP facility.

● Strong working knowledge of cGMP regulations.

● Demonstrated experience with digital validation solutions (ALM) and with the client document management system (BMSDocs), including document number requests, upload and approval routing.

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