Validation Technician (m/f/d)

Summary

The Company is looking to recruit a Validation Technician to manage all validation projects within the business in compliance with applicable regulatory agency standards. Primary duties will include writing and executing validation protocols for facilities, equipment and processes, ensuring they are undertaken according to FDA, EU and AMS standards. This role will be based at the Nuremberg site and report to the Operations Manager, but occasionally travel to the other sites. The position will be permanent.

If you are interested in applying for this position please send your current CV and motivation letter to Christiana Huderer in Human Resources (bewerbung@resorba.com).


Full Description

Key Accountabilities:

• Developing validation project plans and timelines
• To write and execute validation protocols, such as installation, operational and performance qualifications (IQ, OQ, PQ’s), Factory acceptance tests (FAT), site acceptance tests (SAT), Process optimisation, Process validations and Cleaning Validations
• Work within cross functional teams to manage projects
• Ensuring work is completed in compliance with applicable ISO, FDA and all other regulatory agency standards
• Undertake activities related to NC, CAPA and risk management, as required
• Follow and adhere with all company policies and procedures to maintain a safe working environment

The ideal candidate will have:

• Degree in a Science / Engineering / Quality related field or equivalent
• Validation experience within a regulated manufacturing environment
• Understanding of Medical Device Regulations including ISO13485, GMP; FDA QSR an advantage
• Ability to interpret and apply legislation and policy
• Strong analytical and problem solving skills
• Effective written and verbal communication skills
• Ability to work well within a team with a flexible approach and on own initiative
• Knowledge of Health and Safety in the workplace
• Experience of Lean Manufacturing, Six Sigma and continuous improvement practices an advantage
• Previous Quality Engineering experience would be beneficial
• Fluent German and English communication skills