Senior Manager, QA Engineering (Equipment/Lab Methods/Utilities/Facilities)
Core
Providing quality oversight for Site Validation activities and Quality Control Laboratory method and equipment validation in accordance with cGMP.
Role type
Senior Manager, QA Engineering (Validation & Data Integrity)
Builds
Validation and qualification documentation for equipment, utilities, and facilities
Domain
Pharmaceutical manufacturing / Quality Engineering
Required skills
GMP knowledge, risk management, IQ/OQ/PQ protocol design, data integrity, CAPA, root cause analysis, technical authorship, cross-functional negotiation
Preferred skills
Computer Maintenance Management System (CMMS), quality systems software, scientific initiative management
Technologies
Microsoft Office, Maximo, BMSDocs, Infinity, Valgenesis
Responsibilities
Support Qualification and Validation activities for QC and manufacturing equipment, utilities, and facility design; Ensure compliance with validation master plan and facility start-up operations; Establish and maintain procedures for Data Integrity; Manage QA Engineering team and assure job objectives are met
Seniority
Senior, hands-on IC or People Manager