Automation Engineer

Consulting Boston, Massachusetts Waltham, MA, Massachusetts Worcester, Massachusetts


Description

Process Validation Engineer

Experience:


·       Drive validation activities (process and cleaning) and ensure that they are executed per Company requirements

·       Partnering with CMOs and ensuring equipment qualification activities are conducted per Company requirements, which includes reviewing CMO procedures and qualification reports.

·       Lead and drive Validation Lifecycle Management activities to maintain the validated state (CPV, requalification).

·       Work as Validation Lead in cross-functional project teams and partner with other departments like MTS, QC, Process Sciences, QA, Reg Affairs and Tox.

·       Develop and maintain validation program documents including SOPs, Master Plans and Guideline documents.

·       Design and execute process and cleaning validation studies at company sites that are technically sound, compliant with established procedures and aligned with industry best practices.

·       Provide manufacturing support as PIP (person in plant) during PPQ runs and, as needed during routine manufacturing.

·       Provide validation support in deviation investigations and change control.

About Azzur

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.


Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!