Beschreibung
Junior Validation Engineer - German Speaking - Solothurn, Switzerland
Knowledge & Skills:
Required degree/certificates:
Junior Engineer or Technician
Specific technical skills (please detail):
21 FDA 820
ISO 13485
Specific knowledge for the role (please detail):
Good documentation practice
Specific languages:
German - good understanding/English fluent
Competencies:
Familiar with international dealing Companies (Matrix-Organization)
Intercompany Traveling (D-A_CH)
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
To provide support for the validation activities associated with equipment, reagents, facilities, cleaning, test methods, and environment ensuring that all compliance issues and requirements of client 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
Manages relationships externally and internally.
Builds cross-functional and cross-departmental support, fostering overall effectiveness
Fosters harmony within Quality Systems.
Influences and persuades so as to bring about technical and process improvements.
Ensure accuracy and maintenance of the client Validation Master List.
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.
Through effective communication and training initiatives develop staff in projects and validation teams to ensure that validation projects are carried out in accordance with client Policies and Procedures.
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