GxP Recruitment invites applications on behalf of our biopharmaceutical client based in Wiltshire where an excellent opportunity exists for an experienced Microbiologist for a Technical Support Specialist within Production from a Microbiology perspective.
Reporting to the Technical Operations Manager, the role will provide microbiological support and be engaged in continuous improvement, investigations, NCs, reporting, risk assessments, data review and analysts. The postholder will be a single point of contract for all issues in respect of microbiology performance of the facility.
Key duties include:
* Be the point of contact and provide oversight and support to Manager and broader integrated team on all environmental and sterility assurance issues and activities.
* Ensure all investigations, non-conformance reports, action items, change controls are raised and closed in accordance with agreed timelines.
* Be aligned with the Sterility Assurance Program Board.
* Support the management and development of improved and new processing techniques in the various processing activities.
* Troubleshoot and resolve issues and provide technical support into process investigations.
* Collate and share technical information with internal functions to benefit the production methods, teams and department.
* Provide specialist training to staff in processing techniques and theory.
* Assist colleagues in providing technical specialist input as required, in developing production and technical strategies, identifying new opportunities as they arise and responding to external queries and complaints.
The ideal candidate:
* Degree qualification in appropriate discipline
* Previous experience in biopharmaceutical manufacturing
* Significant understanding of cGMP guidelines
* Hands-on experience in Grade A-D environments
* Experience generating GxP related documentation.
* Clean room experience
* Excellent technical report writing
Methods Of Production