Lead the validation and implementation of key processes for the launch of a new pediatric vaccine, collaborating with global teams to ensure successful technology transfer and highest quality standards
Job Summary
Lead the validation and implementation of key processes for the launch of a new pediatric vaccine, collaborating with global teams to ensure successful technology transfer and highest quality standards.
Lead the validation of conditioning, filling, transport, and cleaning processes for a new pediatric vaccine, ensuring robustness and reproducibility of the transferred process.
Collaborate with teams in France for technology transfer, including scaling, engineering batches, and process validation batches (PPQ).
Matching Summary
Lead the validation and implementation of key processes for the launch of a new pediatric vaccine, collaborating with global teams to ensure successful technology transfer and highest quality standards.
Skills & Requirements
Must-have
Process validation
Tech transfer
GMP compliance
Risk analysis
COFEPRIS regulations
Nice-to-have
Cross-cultural collaboration
Results-oriented
Proactive approach
Key Requirements
Pharmaceutical or biotech process validation experience
Experience with IQ/OQ/PQ qualification methodologies
Experience with FMEA, HACCP risk analysis
Experience with GMP regulations (FDA 21 CFR, EU GMP Annex 1, COFEPRIS)
Degree in Chemical, Biochemical, Pharmaceutical, Industrial Engineering or QFB