GMP Commissioning Lead – Pharma Facilities

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

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.