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About the role
Key responsibilities & impact- supports equipment selection, CMO selection strategy, management of equipment qualification and process validation activities
- provides floor support during operations of off-site manufacturing
- reviews process data to ensure operational consistency after the processes are successfully transferred
- assists with investigation and root cause determination and identifies/implements CAPA for manufacturing deviations
- trends process performance and collaborates with teams to establish/improve process capability
Requirements
What you’ll need- BS/BA in engineering
- 2 years of experience in a pharmaceutical / biologics cGMP environment or equivalent combination of education and experience
- up to 25-50% travel to contract manufacturers or business partners
Benefits
Comp & perks- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave) for eligible employees at all levels
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
equipment qualificationprocess validationdata analysisCAPA implementationprocess capability improvement
Soft Skills
collaborationproblem-solvinginvestigationroot cause analysis