Senior C&Q Engineer - Pharma Packaging

qualityconsultinggroup; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to join our team in Puerto Rico & USA, focusing on commissioning, qualification and packaging in pharmaceutical manufacturing. You’ll develop strategies, lead risk assessments, and oversee IQ/OQ/PQ across GMP-regulated environments.

The role requires a Bachelor's degree in Engineering, packaging experience in pharma, and strong GMP/GDP knowledge, with excellent cross-functional collaboration and documentation practices.

Qualifications

• Bachelor's degree in Engineering, Packaging Engineering, or related technical field.
• Experience in packaging/engineering within pharmaceutical manufacturing.
• Strong GMP and GDP knowledge.
• Knowledge of primary and secondary packaging materials.
• Familiarity with distribution testing standards (ASTM D4169, ASTM, ISO, TAPPI, USP, EP).
• Strong project management and communication skills.
• Ability to work cross-functionally and adapt to priorities.
• Experience writing test protocols and technical reports.

Responsibilities

• Independently profiles process optimization strategies and troubleshoots issues in operations and manufacturing.
• Applies engineering principles to design and implement system modifications and projects.
• Develops qualification plans and lead CQ activities (IQ/OQ/PQ).
• Define system boundaries and conduct risk assessments to determine scope.
• Coordinate with vendors and internal teams during startup and validation.
• Review and approve commissioning documentation and test results.
• Ensure GMP/GDP compliance and maintain electronic document lifecycle.
• Collaborate with Engineering, Validation, QA, Manufacturing and Supply Chain.

Skills

GMP knowledge

GDP knowledge

Packaging knowledge

Project management

Cross-functional teamwork

Communication skills

Education

Bachelor's degree in Engineering

Job description

Quality Consulting Group, LLC is seeking a talented engineer to join our team in Puerto Rico & USA, focusing on commissioning, qualification and packaging in pharmaceutical manufacturing. You’ll develop strategies, lead risk assessments, and oversee IQ/OQ/PQ across GMP-regulated environments.

The role requires a Bachelor's degree in Engineering, packaging experience in pharma, and strong GMP/GDP knowledge, with excellent cross-functional collaboration and documentation practices.