Validation Engineer

Validation Engineer

Randstad Professionals are one of the leading recruitment companies in Switzerland and with a dedicated IT contracting team in Zurich. We are excited to help you in your search. We focus on finding the best contracts for the best contractors.

We are looking for a 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 our client's 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
- Update/compile process validation documents (Engineering Studies, IQ, OQ, PQ) and execute/follow these validations
- 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's Policies and Procedures
- Facilitates, encourage and coordinate continuous improvement with respect to validation activities
- Update/compile URS (User Requirement Specifications) for the machine and modules of it
- 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
- Lead by example, inculcating the Credo values in all actions within the workplace

Technical Profile Requirements

- 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 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
- Language proficiencies: Fluent in English and German spoken and written. Documents are to be compiled in both languages.

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

Whether this role is the right fit or you would like to see if there are others that do, our dedicated and expert team is looking forward to hearing from you.

Good to know you!