Within our Quality & Compliance unit we are looking for an experienced computer system validation engineer who is ready for the next step, and who wants to grow towards a role as team lead.
As an experienced computer system validation engineer you will provide support with the implementation of software systems that are used in lab and production environments within the pharma. It is your mission to guarantee the quality of these software systems. Within software validation there is a very wide range of possibilities, ranging from Excel sheets, medical devices, websites, HPLC software to very complex systems: MES, LIMS, SAP, etc.
In addition, we are looking for a future manager: someone with a good dose of people skills and with the ambition to further develop his/her leadership skills.
You will embark on a trajectory in which you will further develop your leadership skills through trainings, workshops and on the job learning. This programme is the ideal step for ambitious candidates with technical expertise who want to grow into a role as service manager, project manager or team lead.
- You are responsible for independently setting up and documenting a risk-based validation strategy
- Together with the business requirements and test protocols, you draw up
- You will assist the customer with regard to compliance with regulations such as Cfr21 Part 11 / Annex 11
- You are co-responsible for determining the impact of changes and drawing up deviations
- You will help draw up and adapt work instructions and SOPs
- In your future managerial role, you will lead an Ordina team, with the aim of guaranteeing a high-quality customer experience: incoming projects are planned and delivered on time with a high degree of quality
- You communicate at different levels in the customer organization and build and maintain the customer relationship
- You think along with us about building, expanding and improving the service or the team for which you are responsible
- You ensure that the workload/capacity is in line with the profitability and quality of the services provided
Who we’re looking for
- You have a master’s degree in a scientific field (Industrial Ir, Bio Ir, Chemistry, Biotechnology, Pharmacy, …) or equivalent through experience
- You have at least 3 years of experience with computer system validation (CSV) within a GMP environment
- You are familiar with the standards and guidelines (GAMP5, GMP, 21CFR Part 11, ISO, …) and concepts such as QMS, Data Integrity, CAPAs, GDP, …
- You think analytically and pragmatically
- Trust and partnership are two of the driving forces in your daily work
- You dare to take responsibility
- You can keep an overview and are good at setting up plans and structures
- You are quality-oriented and customer-minded
You can communicate clearly and assertively, both in Dutch and English
What we offer
- You will contribute to projects for top companies in the pharma and life sciences sector, both nationally and internationally
- You work in an environment with a focus on knowledge and innovation, an open no-nonsense corporate culture
- A professional and dynamic environment with down to earth colleagues where new ideas and initiatives are encouraged
- You will keep your technical and social skills up to date through our Ordina Academy, workshops and conferences and will be supported in your further growth
- You can participate in fun business and team building activities
- You will receive a comprehensive salary package with additional benefits such as a company car, laptop, insurance package, meal vouchers, expense account, etc.
- You can optimize your net salary thanks to our IP-reward