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Job Details

Validation Engineer - (Fluent German and English)

Company: ProClinical Ltd
Location: Stuttgart
Reference: QA.IG.15395
Closing Date: 23 Feb 18
Type: Contract
Salary (£): Negotiable
Benefits:

Job Summary:

ProClinical is seeking a Validation Engineer for a medical device company, to be based in Stuttgart on a contract basis. ...

Requirements:

ProClinical is seeking a Validation Engineer for a medical device company, to be based in Stuttgart on a contract basis.

Job Responsibilities:

* Prepare detailed schedules and plans, clearly defining the key actions in the delivery of continuous improvement projects
* Identify, develop and maintain stakeholder relationships
* Write protocols and protocol reports for validation or trial purposes
* Development of Validation Plans, Cycle Development, Performance Qualifications, Requalification Protocols and System Summary reports for Autoclaves, Steam in Place Systems and Controlled Temperature Chambers (CTCs).
* Prepare, execute, document and report validation protocols in line with GMP's and other regulatory requirements and standards.
* Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
* Present analytical information to the Operations team
* Implementing qualification program for initial qualification of laboratory and/or manufacturing equipment.
* Document preparation for EQAs, IQs, Operational Qualifications OQs, and where applicable Performance Qualifications (PQs).
* Summary Reports (SRs), Trace Matrices (TMs)
* This includes execution for IQ, OQ and where applicable, PQ.
* Maintain progress trackers for doc prep and execution activities.

Skills and Requirements:

* Degree in Engineering, Chemistry, Biochemistry or Biology or several years of Validation Engineering experience
* Knowledge of the use of Biological indicators and Thermal Mapping to demonstrate system sterility/temperature control
* Hands-on experience with temperature mapping equipment, eg Ellab, LIVEs or equivalent
* Ability to write protocol reports for validation or trial purposes
* Up to date knowledge of regulations
* Validation concept (validation cycle) understanding would be an advantage
* Critical thinker with excellent communication skills

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Ivan Gitardi on +44 203 0789 551 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Validation Engineer -  (Fluent German and English)

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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