$80,000.00 - $90,000.00 /Year
Sr. Quality Engineer - Critical Systems
Core functions include:
Development, evaluation, and ownership of all quality characteristics of the plant facilities and equipment quality system (critical systems).
CAPA management of critical systems and metrology operations.
Execute and/or coordinate Risk and Gap Assessment analysis to ensure that the plant critical systems and equipment are under an acceptable level of compliance.
Proactively lead facilities and equipment quality system enhancement projects to decrease the likelihood of action resulting from a regulatory inspection.
Work in partnership with manufacturing operations, research and development, quality control and assurance, engineering, maintenance and support areas to solve problems and provide expertise on compliance issues and corporate quality policy requirements relating to critical systems.
B.S. Degree Engineering or technical science degree. CQE or Black Belt certification a plus.
Minimum 5 years QA/QC experience in pharmaceutical or other highly regulated industry
Working knowledge of cGMP practices. Working knowledge of FDA, USP, ISO, and ISPE trends and guidelines.
Must have experience in qualification and validation practices.
Experience troubleshooting problems related to critical systems and equipment (Water, HVAC, Pest Control, Lyophilizers, Vial Washers, etc)
Strong technical writing ability