Validation Engineer
Sophie Steels
Senior Recruiter
+32 496 49 18 21
Description de l'emploi
Science
Talents is part of House of Talents, an international HR services group specialized
in bottleneck professions. You will be working in a no-nonsense environment
where team spirit, drive and eagerness to learn are key.
We are very
open and communicative go-getters who are keen on results and quality.
To further
strengthen our growth, we are constantly looking for new colleagues within
Project Staffing.
Working as
a consultant equals working with a fixed contract at Science Talents. You get
the chance to work on different projects in your field of expertise and gain
new experiences in life sciences, the chemical sector, and the food
industry.
Work is
important; however, we also attach great value to a healthy dose of fun@work! Triggered?
Let's meet!
For our client we are looking for a Validation Engineer
You wil be responsible for:
Development, implementation and execution of URS, SIA, DQ, IQ, OQ, PQ, RV and TM activities. Develops, implements and executes validation studies for cGMP-critical process systems to demonstrate compliance to cGMP-, User- and Regulatory requirements. Hands-on activity envisaged in relation to this.
- Performs validation of systems for which there is industry precedence but standards require interpretation to the particular case and in accordance with cGMP , cGLP’s and the Procedures.
- Ensures that the Validated Status of process systems is in compliance with cGMP at all times.
- Ensures projects (moderate scale & complexity) are managed in conjunction with all required Our client and cGMP regulatory standards.
- Keeps current on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements. Provides technical assistance on current US FDA and EU validation requirements.
- Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for process systems.
- Responsible for the validation documentation through approval and implementation.
- Provides input in review/assessment of changes to as whether they impact the validated status and validation-documentation, as appropriate.
Profil
- Knowledge of CGMP requirements in a regulated environment.
- Full understanding of relevant quality and compliance regulations.
- Capable of troubleshooting validation issues.
- Good knowledge of quality management systems
- Experience: 2-4 years experience working in a Healthcare manufacturing environment
Will you become one of us? Join a financially sound company and become part of a group of no fewer than 2,500 top colleagues! We cannot wait to meet you! Fill in the form below and we will reach out to you soon.
contract of indefenite duration, included:
* company car + fuel card
* Health insurance
* Meal vouchers of 8€ per day worked
* Net allowances
* Group insurance
* Smartphone subscription
* end of year bonus (13th month)
* Eco vouchers