We are seeking a strong Validation professional to develop and manage a GMP compliant validation program. Oversee and execute validation activities that support multi product manufacturing facilities. Build in-house validation expertise and ensure GMP compliance, good business practices, current regulatory requirements (US and international), and applicable standards are embodied in the Therion validation program and policies. Work in partnership with Quality, Regulatory, Manufacturing, Facilities, and Process Development to manage validation activities to assure they are performed in compliance. Interpret evolving regulatory requirements and quality standards regarding validation systems, processes, operations, and documentation. Monitor change control (re-validation) and validation derivatives. Develop, with QA, metrics to trend validation activities.

We are looking for candidates that embrace our core values of Integrity, Innovation, Collaboration, Compassion, Commitment and Excellence we also ask that you have a minimum of 8 years in Validation, QA or Engineering fractions in a FDA-regulated manufacturing environment. Minimum 3 years management experience with supervisory or project management experience. Experience executing facility, equipment and process validation projects. Biological products experience preferred. Bachelors degree in Engineering or related life science.

For full immediate consideration, interested, qualified candidates are encouraged to email their resume and cover letter to:

[email protected]
Therion Biologics Corporation
Human Resources
76 Rogers Street
Cambridge, MA 02142
Fax: (617) 475-7249

For more information on Therion please see our website at www.therionbio.com

Therion is an equal opportunity employer.