Validation/Quality Engineer

Vor Ort
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keine Angabe
Harvey Nash IT Recruitment Switzerland
flag_no Schweiz

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Place of work: Grenchen
Project Start date: (being able to start ASAP is a big advantage)
Project End date:
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).