Senior C&Q Engineer — Pharma Packaging

Quality Consulting Group, LLC; Juncos (PR); Hybrid; USD 90,000 - 150,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a highly motivated professional to join our team in support of commissioning and qualification activities for pharmaceutical manufacturing and packaging. You will work across operations, validation, QA, and manufacturing teams to ensure all systems meet regulatory and internal standards.

Responsibilities include developing qualification plans, leading risk assessments, coordinating with vendors, and documenting IQ/OQ/PQ activities to support compliant

Qualifications

• Bachelor's degree in Engineering or related field is required.
• Experience in packaging/engineering within final product manufacturing in pharma/biotech.
• Strong GMP and GDP knowledge.
• Knowledge of packaging materials and standards is essential.
• Familiarity with distribution testing standards (ASTM D4169, ASTM, ISO, TAPPI, USP, EP).
• Experience writing test protocols and conducting packaging/testing for qualification.

Responsibilities

• Characterize process optimization strategies and troubleshoot operational issues in operations, manufacturing, pilot plant or capital projects.
• Apply engineering principles to design and implement major system modifications and projects.
• Develop and implement the overall Commissioning & Qualification strategy aligned with regulatory requirements.
• Define system boundaries and identify direct/indirect impact systems.
• Lead risk assessments (ISPE Baseline, ASTM E2500) to determine qualification scope.
• Develop C&Q plans, schedules, and resource forecasting.
• Oversee commissioning activities including FAT, SAT, and field commissioning.
• Ensure systems are installed and operate per design specifications.
• Coordinate with vendors and contractors during startup activities.
• Review and approve commissioning documentation and test results.
• Author, review, and approve IQ/OQ/PQ protocols.
• Maintain traceability from URS through testing.
• Prepare qualification reports and support validation summaries.
• Collaborate with Engineering, Validation, QA, Manufacturing, and Supply Chain teams.

Skills

Project management

Problem solving

Interpersonal skills

Written communication

Verbal communication

Quality systems knowledge

GMP knowledge

GDP knowledge

Packaging experience

Education

Bachelor's degree in Engineering or related field

Job description

Quality Consulting Group, LLC is seeking a highly motivated professional to join our team in support of commissioning and qualification activities for pharmaceutical manufacturing and packaging. You will work across operations, validation, QA, and manufacturing teams to ensure all systems meet regulatory and internal standards.

Responsibilities include developing qualification plans, leading risk assessments, coordinating with vendors, and documenting IQ/OQ/PQ activities to support compliant