Join a growing biotech company in the final stages of FDA submission!
Were looking for a hands-on Validation engineer with strong experience in writing and executing validation protocols and reports. This is a key role reporting directly to the Engineering Manager.
Responsibilities:
Write and execute validation protocols (IQ/OQ/PQ)
Prepare comprehensive validation documentation including plans, protocols, reports, deviations, and CAPAs
Collaborate with cross-functional teams: Engineering, QA, RA, and Manufacturing
Support internal and external audits, including FDA readiness
Maintain and improve validation procedures in compliance with GMP, FDA, and ISO standards
Requirements: B.Sc. in Engineering, Life Sciences, or related field
At least 3 years as Validation engineer
hands-on experience in validation within pharma/biotech industry
Proven experience in writing and executing protocols and validation reports
Solid understanding of regulatory requirements (GMP, FDA, ISO)
Detail-oriented, self-motivated, and capable of managing multiple tasks
High-level English (written and verbal) a must
Advantages:
Experience in startups or companies preparing for FDA submissions
Familiarity with aseptic manufacturing
This position is open to all candidates.
