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Microbiology & Sterilisation Technical Manager

4 months ago

Skipton, United Kingdom Russell Taylor Full time

**Microbiology & Sterilisation Technical Manager**

**Type**: Permanent

**Salary**: Highly competitive and dependant on experience

**Benefits include**: 6.6 weeks holiday including BH, onsite gym & canteen, private healthcare insurance, dental plan, discounted high street shop vouchers, free parking, bonus scheme

**Hours of work**: Monday - Thurs 8-16.30, early finish on a Friday (13.00)

Flexible working, can start the day at 7am and finish at 3.30pm, or 9am and finish at 5.30pm
- there are QC, R&D and Micro Labs onsite too.

**The role**:

- Managing and developing the Microbiology and Sterilization Technical Teams.
- Supporting the wider European Scapa Healthcare business to ensure understanding and compliance with business and regulatory standards, specifically in relation to Microbiology and Sterilization processes.
- Ensuring Microbiology Laboratory test methods are designed and validated as per customer requirements and applicable industry documentation (e.g., ISO standards)
- Serve as point-of-contact for the Microbiology Laboratory contract customers, managing customer experience too.
- Manage quotations for Microbiology Laboratory contract activities, completing periodic reviews to ensure on-going profitability.
- Oversee qualification and re-qualification activities for contract ethylene oxide (EO) and moist heat sterilization processes (including annual paper reviews to determine extent of re-qualification activities)
- Execute annual SAL product family reviews for irradiated customer products (as applicable)
- Support technical activities associated with the Cobalt-60 Irradiator including (but not limited to) process improvement and source replenishment.
- Work directly with Project Leaders and/or members of the Microbiology/Sterilization Technical Teams to define product and sterilization needs for radiation, ethylene oxide (EO) and moist heat sterilized products including validation (as required).
- Support the Supplier Quality function by completing Quality/Technical assessments of contract sterilization facilities and associated suppliers of sterilization materials/consumables (e.g., dosimeters)
- Lead/support customer and regulatory audits, related to Microbiology and Sterilization process.
- Execute periodic environmental monitoring and bioburden warning/action level reviews, implementing new values (as applicable) in accordance with their QMS procedures (e.g. Change Control).
- Provide Technical expertise for completion of Failure Investigations, Root Cause Analysis and CAPAs related to Microbiology and Sterilization non-conformances.
- Develop and maintain metrics for Microbiology and Sterilization for provision to Clients' Healthcare Leadership Team that allow for trending, analysis of data and drive high performance.

The Person:

- Will hold a Degree in a Microbiology related field
- Strong technical management experience within Microbiology testing
- It would be highly advantageous to have experience working with the Sterilization processes in a related field (preferably Healthcare)
- Experience of customer management
- Working knowledge of radiation, ethylene oxide (EO) and moist heat sterilization. Knowledge of other sterilization modalities (e.g. e-beam) advantageous.
- Working knowledge of statistics
- Previous management experience required