SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Groningen Netherlands.

The Company

This medical device company produces products of the highest quality. They constantly strive to reduce their costs in order to maintain reasonable prices. Orders must be executed quickly and flawlessly. An innovative company looking for a strong Validation Engineer to provide support activities.

Role Description

Supporting validation activities associated with process, test and utility equipment for producing medical devices and ensuring that all requirements of the company policies and procedures are addressed.

Responsibilities

- Serves as technical expert for the Validation process and responsibilities to ensure compliance
- 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
- Create user Requirements Checklist
- IQ protocols, Trace ability matrices, Validation Master Plans, Validation Protocols, Summary Reports and other documentation associated with validations
- Ensuring that all validation activities and documents are authorized and appropriate compliance approval is gained
- Making sure that all validation activities are carried out and reported in a timely manner
- Process knowledge and documentation

Preferred:
- In depth knowledge of ISO 13484, 21 CFR 820, 21 CFR 11
- High understanding of GMP, Compliance, Validation Practices

Requirements

- Individual must also be an active team member in Validation activities Methodology/Certification Requirements
- Qualification in an appropriate discipline (e.g. Engineering, Information Systems or Life Science with additional IT qualification with a broad technical/educational skills base
- Minimum of 2-5 years' of working experience in a regulated environment and a minimum of 2 years which has been spent carrying out validation and or testing activities

A degree in an appropriate discipline (e.g. Engineering, Information Systems, Life Sciences or an IT qualification with a broad technical/educational skills base and substantial related experience
Minimum 2-5 years working in a regulated industry with a minimum of 2 which has been spent carrying out validations

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Helene de Vries.