Validation Engineer - CSV, Switzerland

Vertragsart:
Vor Ort
Start:
ASAP
Dauer:
6 months
Von:
Michael Bailey Associates - UK Contracts
Ort:
Solothurn
Eingestellt:
10.01.2017
Land:
flag_no Schweiz
Projekt-ID:
1266059

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For your Medical Devices client in Switzerland, we are urgently seeking a Validation Engineer with good experience in CSV.

Job title: Validation Engineer

Duration of contract: 6 months

Location: Solothurn, Switzerland

Language: Fluent in German and English

Your role:

  • Originate and approval of Test Method Validations including of determination of sample size and worst case parts
  • Draft and review Job Breakdown Sheets including conducting of 4-Step Method training
  • Establish adequate documentation for CAPA action
  • Conduct transfers of TMV protocols and plans Originate requested documents for validation and computer system validation with support of Subject Matter Experts
  • Coordinate actions and assure that deliverables are completed on time Serves as technical expert for the Validation process and responsibilities to ensure compliance
  • 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
  • Review and approve Validation Master Plans, Protocols, Summary Reports and other documentation associated with validations, as appropriate for each validation exercise.
  • Ensure all validation activities and documents are authorized and appropriate compliance approval is gained.
  • Ensure that all validation activities are carried out and reported in a timely manner.
  • Ensure compliance through assisting in audits.
  • Facilitates, encourage and coordinate continuous improvement with respect to validation activities.
  • Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment

Your experience:

Technical Profile Requirements

  • Knowledge of bespoke validation.
  • Process knowledge and documentation.

Desirable:

  • In depth knowledge of 21 CFR 820, 21 CFR 11 and 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.

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 base
  • 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.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.