Senior Validation Engineer

Location: Netherlands

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 Pharmaceutical organisation, based in Zuid-Holland Netherlands.

The Company

This company is world leader in the area of vaccine development and they are currently looking for a Senior Engineer who will be part of the Technical Operations Department. This site is part of the global Technical Operations organization.

Role Description

You will be responsible for the validation and standardization of processes and equipment within the company. You will manage Life Cycle Management projects and improve projects where needed. The company accomplishes this through their broad technical competency, global reach and local execution power. This job is not only very dynamic but also very diverse.

The company is looking for somebody who likes challenges, is collaborative and is keen on working within local as well as global project teams. They are looking for somebody with strong knowledge and experience in bio processing and compliance. Who is self starting and likes to take initiative and can define new strategies for implementation of new equipment and products. In addition a person who demonstrated to lead projects and likes to coach and train team members.

Responsibilities

- Primary responsible that validation studies are executed conform site standard and the company guidelines.
- All the studies must meet quality requirements
- Encompasses: Cleaning, mixing and sterilization validation of production equipment
- Responsible to maintain and continue to improve the validation process
- Defining and developing new validation strategies for the implementation of new equipment and new product introduction
- Training and coaching engineers in GMP compliance and perform the internal review of protocols and reports
- Preparation of protocols and execution of studies
- Lead and support the coordination of studies
- Participate in multidisciplinary projects as independent core team member to represent the Technical Operations department
- Assessment of change control and preparing of validation assessments
- Lead and Support in deviation investigations
- Establish and maintain contact with colleagues of other sites

Requirements

- Minimum Bachelor or Master in Science in a relevant field
- At least 3 years' of relevant experience in the (bio-) pharmaceutical industry
- Proven experience with GMP and compliance
- Expertise in process excellence and/or projectmanagement is preferable
- Fluent in English language, Dutch is considered a plus

Other information

Are you precise, accurate, structured, flexible and costumer focused?

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.