Senior Validation Engineer in Colorado

Global Life Science Hub is partnered with a niche, specialist biopharmaceutical company offering next-generation drug delivery technologies and an advanced pipeline of oral and biosimilar drugs. With 2 FDA approvals and new in-house manufacturing capabilities, they are primed to triple their production into 2025 to improve patient outcomes through innovative drug delivery technologies and therapeutic solutions.

The Validation Engineer will play a pivotal role in ensuring the efficiency, compliance and reliability of critical systems and processes within the organisation. The appointed candidate will be tasked with developing and executing validation protocols, encompassing a broad spectrum of other responsibilities.

Responsibilities:

• Develop protocols for Equipment/Facility/Utility and Instrument Qualification (first in kind) and create Validation/Qualification Policies.
• Initiate Change Controls independently, providing validation...