Validation Engineer
Contracting – Brabant Wallon
Your responsibilities:
Commissioning and Qualification: Review IQOQ protocols and reports to ensure the qualification of CPP, support the team for risk analysis creation (SRA), review equivalence certificate, write validation plans...
* Validation: According to the client’s standards and procedures, design the validation strategy through PQ protocol redaction, ensure the readiness for PQ validation, coordinate validation (on the floor job expected), manage unplanned events associated with validation, be the contact with QC.
* Product validation: Understand the product validation lifecycle and ensure that the validation strategy is in line with the product validation strategy, support the product steward in product related topic (E&L, holding time, …).
* Change Control: Assessment of the validation impact through eCC assessment (Stakeholder role expected), Coordinate eCC, and be responsible of eCC tasks.
* Project management: Plan and manage PQ activities (material, documentation, people…), support the project planner, animation of meetings/workshops, help the production representative in the understanding of validation requirements.
Your profile:
* University degree (Biotechnology, Agronomy, Chemistry or Pharmacy).
* At least 5 years’ professional experience in pharmaceutical environment, in quality and validation environment.
* Good oral and written communication skills in French & English (for efficient communication with engineering office and suppliers).
* Good Knowledge of GMP Regulated environment related to validation activities.
* Good interpersonal relationship skills - To be a good team player to success in each validation.
* Problem solving and achievement oriented.
* Be organized.
Nice to have:
* Knowledge of freezer dryers, filling lines and isolators would be an asset.
* To maintain and keep up to date its knowledge and experience necessary to the function.
* Ability to take decisions in stressful conditions.
* Proactive and ready to take the lead to make things happen.
* Ability to work under pressure on multiple deliverables within project timelines.
Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
Are you interested in this job? I kindly invite you to apply or send me your CV, lunarosa.doukkali@jeffersonwells.be