Primary and secondary packaging process validation
Device and combination product qualifications
The Senior Validation Engineer will serve patients by ensuring the supply of high-quality products produced at contract manufacturers through global collaboration
Job Summary
The Senior Validation Engineer will serve patients by ensuring the supply of high-quality products produced at contract manufacturers through global collaboration.
Key responsibilities include overseeing validation strategies for Finished Drug Product, determining appropriate sample plans using statistical methods, and authoring validation sections of marketing applications.
The role requires travel within the JAPAC region, specifically Japan, to support contract manufacturing organizations and manage cross-functional project teams.
Matching Summary
The Senior Validation Engineer will serve patients by ensuring the supply of high-quality products produced at contract manufacturers through global collaboration.
Skills & Requirements
Must-have
Finished Drug Product qualification experience
Primary and secondary packaging process validation
Device and combination product qualifications
Statistical methods for sampling plans
cGMP manufacturing environment experience
Validation lead for NPI or tech transfer
Nice-to-have
Synthetic API manufacturing process validation
Aseptic processing system oversight
Cleaning validation foundation
Complex deviation resolution experience
Global virtual team collaboration
Strong presentation and public speaking skills
Key Requirements
Doctorate degree OR Master's with 4-6 years experience
Bachelor's degree with 6-8 years experience
Minimum 6 years in cGMP manufacturing environment
Prior experience as Validation lead for NPI or tech transfer