In an environment where the digitalisation and automation of our production processes and quality control is a crucial initiative, we are looking for a Computerized System Validation Engineer (CSV) to cultivate this transition for our client in Tilburg. Do you enjoy working in a multidisciplinary, highly technical environment where personal development is one of the company's key priority? Apply now!
Job description
This position is is within the validation team, where you will work as validation engineer CSV closely with production, IT, supply chain and quality departments. Validation projects can include production systems, laboratory systems, facility systems and steady-state activities surrounding these applications. This role requires relevant validation experience with production and laboratory systems used within the pharmaceutical industry. As you will also play a key role in our transition process to automate and digitize the processes and systems, the background in project management will be a differentiator. We encourage candidates who e It is an advantage to have experience (5-7 years) in the pharmaceutical industry, preferably in validation.
Responsibilities
- Executing and/or leading GxP CSV projects in accordance with cGMP, 21 CFR Part 11, GAMP5 and Annex 15;
- CSV Engineer is responsible that GxP systems meet the manufactured use and meet the required requirements;
- Monitoring current Industry Practices and company policies and procedures;
- Maintaining knowledge of cGMP automation/computer systems validation within an EMA/FDA regulated environment is required.
Profile
- A bachelor's or university degree in one of the target areas for the position (e.g. IT, Science or related field);
- You can thrive in a matrix organization, managing the likely of the interface between functional organization and project organization and balancing all the fundamental ones;
- You effectively manage numerous projects/priorities and demonstrate excellent written and practical communication skills;
- Good handling in time-sensitive and safe situations with proper risk assessment are also skills that are expected. Given the multitude of projects running within the validation department;
- You possess the ability to learn and work according to the latest industry standards and designated computer validation practices;
- A solid background in one of more of the areas involved, such as validation, GMP and pharmaceutical production and IT.
Benefits
- Employment: year contract through Oxford, intention to extend/takeover
- Salary indication €4500 - €5500 gross per month based on experience
- Working hours: 40 hours per week in day shift
- Region: Tilburg
- Vacaturenummer: 24235
IMPORTANT NOTE: Visa sponsorship is not possible for this position, please do not apply if you do not have a working permit to live and work in the Netherlands. Your application will not be processed.
