Plan, execute, and oversee qualification activities, including IQ/OQ for systems and facilities
Support the Group Technical Unit in global and multi-site engineering projects, expansions, and upgrades
Develop and maintain qualification standards, templates, protocols, and reporting systems
Coordinate and support the qualification of production equipment, utilities, automation systems, and infrastructure
Review qualification documentation, deviation reports, risk assessments, and change controls
Ensure compliance with internal engineering standards and applicable regulations, including GMP, ISO, FDA, and safety requirements
Work closely with site engineering, maintenance, production, quality, and project teams
Support troubleshooting and root cause investigations related to technical systems or failed qualifications
Drive harmonization of qualification practices across multiple company locations
Provide technical guidance and training to local engineering teams
Identify opportunities to improve qualification efficiency and asset reliability
Requirements
University degree in a technical field
5+ years of experience in qualification, validation, technical engineering, or manufacturing support
Strong knowledge of IQ/OQ/PQ and lifecycle qualification principles
Experience working with manufacturing equipment, utilities, or facility systems
Experience in the pharmaceutical manufacturing industry
Understanding of and experience with engineering development models and the preparation of related design documentation
Ability to act independently while also collaborating effectively with cross-functional teams
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Support the Group Technical Unit in global and multi-site engineering projects, expansions, and upgrades
Develop and maintain qualification standards, templates, protocols, and reporting systems
Coordinate and support the qualification of production equipment, utilities, automation systems, and infrastructure
Review qualification documentation, deviation reports, risk assessments, and change controls
Ensure compliance with internal engineering standards and applicable regulations, including GMP, ISO, FDA, and safety requirements
Work closely with site engineering, maintenance, production, quality, and project teams
Support troubleshooting and root cause investigations related to technical systems or failed qualifications
Drive harmonization of qualification practices across multiple company locations
Provide technical guidance and training to local engineering teams
Identify opportunities to improve qualification efficiency and asset reliability
Requirements
University degree in a technical field
5+ years of experience in qualification, validation, technical engineering, or manufacturing support
Strong knowledge of IQ/OQ/PQ and lifecycle qualification principles
Experience working with manufacturing equipment, utilities, or facility systems
Experience in the pharmaceutical manufacturing industry
Understanding of and experience with engineering development models and the preparation of related design documentation
Ability to act independently while also collaborating effectively with cross-functional teams
#J-18808-Ljbffr
Group Lead Qualification Engineer Arbeitgeber: Jobtailor
Als Global Director B2B – Business Development bei uns profitieren Sie von einer dynamischen und innovativen Arbeitsumgebung, die auf Zusammenarbeit und Kreativität setzt. Wir bieten Ihnen nicht nur attraktive Vergütungsmodelle und umfassende Weiterbildungsmöglichkeiten, sondern auch die Chance, in einem internationalen Team zu arbeiten, das Vielfalt und persönliche Entwicklung fördert. Unsere Unternehmenskultur legt großen Wert auf Flexibilität und Work-Life-Balance, sodass Sie Ihre Karriereziele in einem unterstützenden Umfeld erreichen können.
