Serán BioScience

Senior Validation Engineer

Bend, Oregon · Senior

No sponsorshipDetected 179 days ago

Product ManagementFDA RegulatoryLeadershipCommunicationMicrosoft Office

About the role

Those with less experience are encouraged to apply.
As a critical member of the Commercial Steering Committee, the Senior Validation Engineer will be responsible for planning and execution of CQ and validation projects.
Successful candidates will understand that the development and execution of CQ and validation projects requires communication with internal and external cross functional teams.

Preference for those who posses knowledge of Global Regulatory requirements (E.g., FDA / MHRA / EMEA)
Experience with regulatory expectations and industry practices for CQ and Validation using Product Lifecycle approach
Experience with designing CQV plans for Facilities, Utilities, and Process equipment desired
Strong time-management skills and the ability to organize and coordinate multiple projects at once
Ability to prioritize tasks and to keep leadership apprised of performance timelines
Demonstrates leadership skills with ability to motivate and coach cross functional teams
Experience in FAT/SAT of process equipment, and knowledge operating principles of typical OSD process equipment preferred.
Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems

Experience will determine title and salary, with preference given to applicants with over 8 years of experience with Oral Solid Dosage and an interest in leading teams.

Summary: Serán employees accrue over four weeks of paid time off annually.
Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period.
Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions.
Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage.
An Employee Assistance Program provides support for all things related to our employees' wellbeing, along with access to pet insurance.

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

This listing is sourced directly from Serán BioScience's careers page and normalized into a canonical job model.