Hobson Prior currently has an exciting new opportunity within a very patient focused pharmaceutical company based in the US. Our client is looking for a Process Validation Engineer to join them on a permanent basis who will be expected to provide process validation support for manufacturing operations located in Lexington and Cambridge MA, USA.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• Accountable to supply technical assessments on change controls, deviations and investigations, measuring proposed changes to validated processes to recognise requirements essential to maintain validated status.
• To manage process validation related quality systems and use project management skills to arrange those project teams and drive results.
• Contribute in regulatory inspections.
• You will represent process validation team on project core teams and partake in strategy conversations on behalf of process validation in partnership with PV strategy team and aligned with global PV and regulatory requirements.
• Support and interface with global PPQ community of practice where needed to ensure alignment and consistency with global practices.
• To manage process validation Quality Systems, as required, and manage project through to closure per timelines.
• You will deliver technical input to strategy for validation activities.
• Represent process validation during site GMP activities and partake on cross-functional teams.
• Manage development of process validation protocols and other documentation for cell banking, cell culture and purification processes.
• Implementation of process validation studies, as well as data analysis and compilation of data and results into summary and final reports.
• To recognise opportunities for continuous developments, contribute in the deployment of best practices, represent process validation at meetings and support the process validation communications board and community of practice.

Requirements:

• Bachelor's in Biology, Chemistry, Chemical Engineering or related field with a minimum of 5 years relevant experience or Master's in related field with a minimum of 3 years relevant experience.
• The ability to work at all MA site locations as required.
• The person in this role will be required to carry an iPhone and be on call as required to support process validation activities.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.