Commissioning Lead-Construction & Facility Systems

QRC Group; Manatí (PR); On-site; USD 120,000 - 160,000; Full time

Job summary

QRC Group seeks a Commissioning Lead to direct the commissioning of construction and facility systems for a new GMP production autoclave in a sterile packaging area at Manatí, Puerto Rico. You will review designs, develop commissioning plans, and manage turnover packages, with broad interface to contractors and suppliers.

Ideal candidates have 8+ years in commissioning and qualification in pharma/medical device sectors, with strong cGMP knowledge and bilingual skills in Spanish and English.

Qualifications

• Bachelor's degree in engineering with commensurate experience.
• Strong knowledge of cGMP regulations and pharmaceutical manufacturing environments.
• Fully bilingual in Spanish and English, written and spoken.

Responsibilities

• Review the design package and participate in design reviews.
• Develop the Commissioning Execution Plan, system boundary definition package, and Level 3 schedule.
• Define responsibility matrix for protocol development, execution, witnessing and approval across QRC, contractors and suppliers.
• Develop and maintain Turnover Package index and support transfer processes.
• Manage deficiency and punch list log and drive closure with contractors and vendors.
• Author commissioning protocols and reports and route deliverables through document management and validation systems.
• Coordinate execution with mechanical, electrical and controls contractors and equipment suppliers.
• Lead System Turnover Readiness Assessments and Operational Readiness Walkdown.
• Prepare Pre-Startup Safety Review support package and its execution.
• Verify training readiness and maintenance readiness prior to handover to Operations.
• Issue weekly progress reports and participate in project meetings.
• Assemble Final Turnover Package and Handover Report and Final Commissioning Summary Report.
• Support electronic change control closure.

Education

Bachelor's degree in Mechanical, Chemical, Electrical or Industrial Engineering

Tools

ALM

BMSDocs

Job description

Commissioning Lead-Construction & Facility Systems

Manati, Puerto Rico

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.

• 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.