Senior Packaging & Validation Engineer

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 110,000 - 140,000; Full time

Job summary

QUALITY CONSULTING GROUP, LLC is seeking a talented engineer to join its team in a pharma/biotech manufacturing context, supporting in Puerto Rico and the USA. The role focuses on process characterization, commissioning, qualification, and ongoing validation activities across GMP-compliant systems.

You will lead risk assessments, develop CQ strategies, manage documentation, and collaborate with engineering, QA, and production groups to ensure compliant, traceable results.

Qualifications

• Bachelor's degree in Engineering, Packaging Engineering, or a related technical field.
• Experience in packaging and/or engineering within final product manufacturing in pharma/biotech.
• Strong GMP and GDP knowledge.
• Knowledge of pharmaceutical packaging materials and components.
• Familiarity with distribution testing standards (ASTM D4169, ASTM, ISO, TAPPI, USP, EP).
• Strong project management, problem-solving, interpersonal and written/verbal communication skills.
• Ability to work cross-functionally in a dynamic environment.

Responsibilities

• Characterize process optimization strategies and troubleshoot operations in manufacturing environments.
• Apply engineering principles to design and implement major system modifications and projects.
• Develop and implement Commissioning & Qualification strategy aligned with regulatory requirements.
• Lead risk assessments (ISPE Baseline, ASTM E2500) to define qualification scope.
• Develop C&Q plans, schedules, and resource forecasting.
• Oversee commissioning activities including FAT, SAT, and field commissioning.
• Ensure systems operate per design; coordinate with vendors during startup.
• Review CQ documentation and test results; ensure GMP/validation compliance.
• Maintain traceability from URS through testing; execute qualification protocols.
• Collaborate with Engineering, Validation, QA, Manufacturing, and Supply Chain teams.

Skills

Packaging knowledge

GMP/GDP knowledge

Project management

Cross-functional collaboration

Documentation practices

Analytical thinking

Communication skills

Education

Bachelor's degree in Engineering, Packaging Engineering, or related technical field

Job description

QUALITY CONSULTING GROUP, LLC is seeking a talented engineer to join its team in a pharma/biotech manufacturing context, supporting in Puerto Rico and the USA. The role focuses on process characterization, commissioning, qualification, and ongoing validation activities across GMP-compliant systems.

You will lead risk assessments, develop CQ strategies, manage documentation, and collaborate with engineering, QA, and production groups to ensure compliant, traceable results.