Validation Coordinator
Contracting – Puurs
Your Mission
As a Validation Project Coordinator, you will support capital projects related to Aseptic Drug Product production from conceptual design through to full validated operation. Working within the Engineering Quality & Systems team, you will coordinate validation and planning activities, ensuring compliance with internal quality standards and regulatory expectations.
Key Responsibilities
* Support the project lead in coordinating validation activities within the project team.
* Define, compose, and consolidate the overall validation project plan and reports.
* Communicate validation strategy clearly to the team, management, and inspectors.
* Continuously monitor validation strategy execution; escalate or adjust when needed.
* Provide an overview of the validation status and its potential impact on the project timeline.
* Coach project engineers on validation practices and quality system compliance.
* Facilitate and document quality system risk assessments.
* Act as sub-team lead for validation within the project team charter.
* Serve as a bridge between Engineering and other departments.
* Develop and maintain the general project schedule and coordinate milestone planning.
* Identify and assess risks in project timelines; assist with mitigation plans.
* Provide input for internal reporting and management communication.
* Ensure all validation and planning activities align with capital project goals.
Your Profile
* Master’s degree in a scientific discipline (e.g., Engineering, Bioengineering, Pharmacy).
* Minimum of 3 years’ experience in the pharmaceutical industry.
* Solid knowledge of validation principles and quality management systems.
* Familiar with regulatory requirements and functioning as an audit spokesperson.
* Strong organizational and structured project management skills.
* High level of interpersonal and communication skills.
* Fluent in Dutch and English.
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. You’re interested in this job? We kindly invite you to apply or send me your CV, jason.devillers@jeffersonwells.be