Validation Manager

Your challenge:

· Primary role is to manage the Validation and RTC department and cover all technical activities related to Performance Qualification (PQ) Validation and Radiation Technology Center (RTC) in the Däniken Site.
· Person in this role will be recognized as site support and tasks will include irradiator qualification, product qualification, Customer technical support relative to Validation and RTC activities.
· Part of this role is to organize the RTC and validation team daily tasks.

•    Validation  and Radiation Technology Center Management:
· Manage the Validation and RTC department (team of 7 technicians and analysts).
· Manage and track Validation and RTC scheduling (Gamma and X-Ray sterilization).
· Support in implementation of all technical procedures and work instructions (local and global).
· Support Quality team during non-conformance investigation with technical input as required.
· Support radiation facility qualification (IQ, OQ) according to WI.
· Provide technical support to Customers as required.
· Report technical updates (e.g. KPI’s, Technical NC’s; Dosimeter or PQ issues) to Senior Management.
· Support global project and improvement processes as part of the Radiation TechTeam EMEA-APAC.
 
•    Customer Performance Qualification:
· Manage all PQ Validation and special request activities to support the site for Customer(s), Account Manager(s) and Radiation TechTeam.
· Ensure Customer PQ are performed according to WI (Protocol, Dosimeter placement, Report).
· Evaluate process capability of a given product before start of PQ activities and after data analysis.
· Report and investigate any Non-Conformity or deviation during PQ activities.
· Prioritization and scheduling of product validation activities (e.g. dose mapping, samples processing, quarterly dose audit) in collaboration with Sales, Operations and Quality.
· Track PQ activities at each step of the process once PQ activities has been approved by Customer.
 
•    Dosimetry System: 
· Manage dosimeter measurement for PQ, OQ and RTC activities in accordance with WI.
· Manage the dosimetry system calibration activities.
· Organize dosimeter and spare parts ordering and tracking, maintenance, and IT updates for 3 Alanine and 1 CTA dosimetry systems.
· Support the Statistical Process Control development.
 

Your profile:

• Completed studies (level Bachelor) in sciences (physics-chemistry or mathematics)
• Ability to demonstrate mathematical and technical competence for problem solving
• Proficient in use of MS Excel, MS Word
• Able to complete statistical and data analysis using statistical tools such as MS Excel
• Academic knowledge of Quality Systems and working in a regulated environment
• Academic knowledge of Good Documentation Practices (GDP)
• Above average organizing, analysing and math skills (advanced algebra and/or calculus and/or statistics) to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.
• Ability to adapt to changing duties and responsibilities.
• Fluent written and spoken German and English (min. B2)
• Leadership skills

We offer:

• A unique technological working environment
• Active participation in a modern and dynamic global corporate group
• An exciting field of activity
• An attractive salary
• Annual bonus (company participation)
• Annual performance-related salary adjustment
• Annual REKA checks
• Free parking spaces
• Ergonomic workstations (multi-monitoring, notebook)
• Regular team and company events (pizza, barbecue, etc.)
• Annual employee survey & regular employee appraisals
• Internal and external training in a globally pioneering technology
• Free external counselling centre for employees and their relatives

What happens next?:

Please apply preferably online via our application portal. We look forward to receiving your documents with details of your salary expectations and earliest possible starting date. Due to the General Data Protection Regulation, we are unfortunately no longer able to process postal applications. Thank you for your understanding!
 

Let's talk about your prospects in person. If you have any questions about this position, please contact our HR Generalist Paul Lonn at bewerbung@steris.com. We look forward to getting to know you better.