Senior Quality Engineer: Packaging & Validation Leader

Katalyst CRO; North Haven (CT); In loco; USD 110.000 - 150.000; Tempo pieno

Descrizione del lavoro

Katalyst CRO is seeking a highly experienced Senior Quality Engineer to support packaging validation, equipment qualification, process validation, and manufacturing quality activities in a regulated manufacturing environment.

The ideal candidate will have strong expertise in IQ/OQ/PQ validation, packaging and post-sealing equipment validation, statistical analysis, process capability, and Quality Management Systems (QMS).

Competenze

• Bachelor's degree in engineering or life sciences required; advanced degree a plus.
• 5+ years of experience in quality engineering, manufacturing quality, or validation in regulated environments.
• Experience with packaging validation and post-sealing/packaging equipment validation demanded.

Mansioni

• Lead and execute IQ/OQ/PQ validation activities and packaging equipment validation.
• Develop and review validation protocols, reports, test procedures, acceptance criteria, and related docs.
• Support audits and regulatory inspections with validation evidence and technical documentation.
• Perform statistical analysis, process capability studies, and data analysis to improve processes.
• Investigate nonconformances, deviations, CAPAs, and root-cause analysis.
• Collaborate with cross-functional teams (Manufacturing, Quality, Engineering, Operations) to resolve issues.

Conoscenze

IQ/OQ/PQ validation

Statistical analysis

Quality Management Systems

Root Cause Analysis

Formazione

Bachelor's degree in engineering

Advanced degree or professional certifications in Quality/Validation/Engineering

5+ years of experience in Quality Engineering/Validation

Descrizione del lavoro

Katalyst CRO is seeking a highly experienced Senior Quality Engineer to support packaging validation, equipment qualification, process validation, and manufacturing quality activities in a regulated manufacturing environment.

The ideal candidate will have strong expertise in IQ/OQ/PQ validation, packaging and post-sealing equipment validation, statistical analysis, process capability, and Quality Management Systems (QMS).