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Validation Engineer

Description

PHILLIPS MEDISIZE, a Molex Company is hiring a 

Validation Engineer 

based in our manufacturing facility in Trhové Sviny, Jihočeský kraj, Česká republika


Main scope of this position: Responsibility for Pre-production related validation and verification processes based on valid SOP's and assuring that the New Product Introduction (NPI) processes as defined in Product specific Design and Development Plans (DDP) and the applicable documentation is followed according to agreed schedules.


What You Will Do In Your Role

  • Plan, coordinate, execute and monitor design verification and validation testing to directly support the verification and validation master plan 
  • Approve NPI validation documents and other quality documents related to NPI projects 
  • Guide and manage validation executions and associated tests to be performed in the NPI phase and in close collaboration with other related/relevant functions 
  • Develop NPI Quality function within validation and verification process, procedures and related documents 
  • Plan and conduct required advanced trainings in the area of validation and verification processes to Pre-production personnel, support trainings to Production personnel and Quality Engineers
  • Ensure that all project related documents are created and well managed according to the regulations, customer specifications and internal quality standards within validation processes 
  • Participate and lead Change Control Actions 
  • Participate in Risk Management Actions and lead risk management sessions 
  • Thorough documentation and archiving as well as steering others for same 
  • Propose planned deviations and exemptions 
  • Participate in creating and maintaining of quality related instructions and procedures 
  • Actively participate in handling deviations with other experts 
  • Participate in creating response to customer claims and solutions to quality problems 
  • Participate in audits and quality meetings when needed 
  • Participate in Pre-production projects as validation specialist 
  • Participate in customer meetings when acting as validation and quality responsible person for customer projects 
  • Manage project documentation from validation and verification point of view 
  • Participate in industrialization and product development work of the customer projects from validation point of view 
  • Ensure smooth transfer of the project documentation from NPI phase to Mass Production phase 


The Experience You Will Bring

Requirements:

  • Understanding of Plastics materials basics, the construction and technologies of injection moulding tools and automation 
  • Understanding of New Product Introduction and plastics processing knowledge 
  • Having Implemented Quality Management System, both on European corporate and local plant levels 
  • Fluent English language skills (level C1) 
  • Organizational & time management skills 
  • Ability to understand interfaces between organizations and processes incl. SOP's 
  • Ability to form a clear overview of responsible area while paying attention to detail. Detecting causal connections between tasks, schedules and details 
  • Strong teamwork, collaboration and team leadership skills 
  • Continuous improvement, willingness to develop processes in responsible area 
  • Customer orientation and understanding cultural differences 
  • Effective negotiation skills 
  • Fluent IT-skills (MS Office & other applicable IT systems) 
  • Ability to act as main point of contact in responsible area 


What Will Put You Ahead

  • Applicable technical or academic degree, e.g. BSc or MSc in Engineering, Plastic Technology or equivalent knowledge and skills (the FDA requires validation training by an outside entity no later than 6 months from job start date)
  • Minimum 5 years of experience of validation and/or quality in contract manufacturing industry with international customers
  • Strong Knowledge of ISO 13485, 21CFR Part 820 
  • Thorough knowledge of GMP and GAMP 


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