Microbiology & Sterilisation Technical Lead

Il y a 2 mois

Leuven, Belgique MindCapture Temps plein

MICROBIOLOGY & STERILISATION TECHNICAL LEAD
- Diagnostics- LeuvenWHAT IS OFFERED

We offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success.

We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance. Depending on your seniority, a car may be provided.

We provide personalized training to let you grow in the area of
- What you like to do
- What you are good at
- Where and how you want to have an impact

ABOUT THE COMPANY

MindCapture collabs with an innovative start-up company in nanoelectronics and molecular diagnostic technologies. The combination of their and our expertise delivers an experienced and dedicated team, bringing together research knowledge and business acumen, and is united by a desire to see diagnostic systems transform worldwide.

They have established a codevelopment project with a pharmaceutical company specialising in CAR-T cell & gene therapies. In order to lead and support a co-development project, we are looking for a Microbiology & Sterilisation Technical Lead to manage the implementation of new aseptic processes.
- Advise and participate in material selection and sterilization
- Ensuring Microbiology Laboratory test methods are designed and validated as per customer requirements and applicable industry documentation (e.g., ISO standards)
- Ensuring DNA-removal processes and sterilization processes are aligned and/or compatible
- Serve as point-of-contact for the Microbiology Laboratory contract customers, managing customer experience.
- 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.
- 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.

REQUIRED COMPETENCES & SKILLS
- Degree in Microbiology, Engineering or a related field, demonstrating a strong educational foundation.
- Extensive technical management experience in microbiology testing, showcasing effective leadership and supervision skills.
- Valuable experience in sterilization processes, particularly in the healthcare industry, providing a competitive advantage.
- Strong background in customer management, fostering positive client relationships.
- Working knowledge of radiation, ethylene oxide (EO), and moist heat sterilization, with familiarity in other modalities like e-beam.
- Proficiency in statistics for accurate data analysis and interpretation.
- Previous management experience, highlighting leadership and team motivation skills.

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