Role DescriptionYou 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 informationAre 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.