This role involves leading the lifecycle management of analytical instruments and non-analytical utilities to ensure data integrity and regulatory compliance across global markets
Job Summary
This role involves leading the lifecycle management of analytical instruments and non-analytical utilities to ensure data integrity and regulatory compliance across global markets.
The successful candidate will drive Computer System Validation activities per GAMP 5 and EU GMP Annex 11 while managing cross-functional project teams and vendor qualifications.
Johnson & Johnson offers an inclusive work environment with opportunities for ongoing development in a high-impact role shaping laboratory reliability and automation.
Matching Summary
This role involves leading the lifecycle management of analytical instruments and non-analytical utilities to ensure data integrity and regulatory compliance across global markets.
Skills & Requirements
Must-have
GMP environment equipment qualification
Computer System Validation CSV experience
IQ OQ PQ lifecycle documentation
Data integrity controls implementation
GAMP 5 21 CFR Part 11 EU GMP Annex 11
Nice-to-have
TrackWise deviation management experience
SAP and electronic document management
Virtualization VMware knowledge
Lab automation integration exposure
German language proficiency B1 or higher
Key Requirements
MSc or PhD in Natural Sciences Engineering or related field
Bachelor's degree with substantial relevant GMP experience
Proven experience qualifying laboratory equipment in GMP environment