Beschreibung
Place of work: Grenchen
Project Start date: 01.03.2017 (being able to start ASAP is a big advantage)
Project End date: 29.09.2017
Workload/weekly working hours: 100%/40 hours
Validation Engineer
To provide support for the validation activities associated with an automated inspection, Laser marking and packaging machine ensuring that all compliance issues and requirements of Johnson & Johnson Validation Policies and Procedures are addressed.
Primary Tasks and Responsibilities
* Managing Complexity/Technical Accountability
* Serves as technical expert for the Validation process and responsibilities to ensure compliance
* Continuous Learning/Managing Risk
* Resolves & manages technical operational problems in area of expertise
* Suggest and sometimes may implement innovation and continuous improvement within the Validation process
* Implements initiatives in the Validation Process that will deliver customer value at lowest cost.
* Facilitates successful team behavior within Quality Systems and across functional areas
* Knowledge of bespoke validation
* Process knowledge and documentation.
Desirable:
* In depth knowledge of European regulations associated with the medical device industry
* High understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
* Working experience of validation computer systems for use in a FDA regulated environment.
* Basic knowledge in statistics
Non-Technical Profile Requirements
* Must be able to lead and give direction to Validation Projects and Teams.
* Individual must also be an active team member in Validation activities Methodology/Certification
Requirements
* Qualification in an appropriate discipline (eg Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills based
* Minimum of 2 years working in a regulated environment a minimum 1 of which has been spent carrying out validation and/or testing activities.
Desirable:
*A degree in an appropriate discipline (eg Engineering, Information Systems, or an IT qualification) with a broad technical/educational skills base and substantial related experience
* Minimum of 2 - 5 years working in a regulated industry a minimum 2 of which has been spent carrying out validations.
Non-Technical profile requirements:
* Some flexibility in working hours is required
* Must be able to work on multiple simultaneous tasks with limited supervision
* Quick learner, motivated self-starter
* Excellent customer service, interpersonal, communication and team collaboration skills
* Able to follow change management for internal guidelines.
* Language proficiencies: Fluent in English and German spoken and written. Documents are to be compiled in both languages. Preferably already worked for Synthes in functions Manufacturing Engineer, Quality Engineer or Validation Engineer (accordingly covered trainings, expertise in Agile and SAP).