Manufacturing Validation Lead

At MindCapture you are not just starting a new role. You are joining a community that invests in your development and gives you the opportunity to grow in a meaningful technical career within healthcare.

You can count on:

• A competitive salary with a full benefits package including meal vouchers, eco vouchers, health insurance, group insurance, net expense allowance and a company car with charging or fuel card
• Personal growth support with tailored training and clear career development
• A stable environment where your technical skills directly contribute to improved patient care
• The chance to work with high tech diagnostic systems at top tier healthcare institutions
• A warm and collaborative culture focused on trust, ownership and long term impact

As Manufacturing Validation Lead, you will act as a Quality validation subject matter expert supporting externally manufactured products and transport processes. You will oversee validation documentation, lifecycle activities, change impacts and process validation while ensuring compliance with GMP, GDP, global standards and international regulatory requirements.

Key responsibilities

• Validation oversight: Create, review, approve and execute validation plans, protocols, risk assessments and reports.
• External manufacturing: Review qualification and validation documentation from external manufacturing partners.
• Transport validation: Review and approve transport validation packages and support study execution.
• Lifecycle management: Support validation throughout the lifecycle of externally manufactured products.
• Quality assessment: Assess validation impacts from changes, deviations, audit findings and CAPAs.
• Process validation: Review validation reports and support continued process verification activities and studies.
• Regulatory support: Act as validation Quality expert for submissions, variations and Health Authority questions.
• Compliance: Ensure validated processes comply with GMP, GDP and applicable global requirements.
• Audit support: Represent validation Quality expertise during external partner audits and regulatory inspections.
• Continuous improvement: Contribute validation expertise, best practices and improvement opportunities across specialist communities.

Required competences & skills

• Validation expertise: Broad knowledge of risk based qualification and validation approaches.
• Lifecycle knowledge: Expert understanding of validation lifecycle principles and their practical application.
• Qualification experience: In depth experience with equipment qualification, requalification and shipping validation.
• Regulatory knowledge: Strong experience with current GMP requirements, ISO 13485 and applicable audit frameworks.
• Quality systems: Experience assessing changes, deviations, CAPAs and audit or inspection findings.
• Communication: Excellent written and spoken English with strong attention to accuracy.
• Stakeholder management: Strong interpersonal, negotiation and cross functional collaboration skills.
• Project management: Ability to manage multiple projects, priorities and stakeholders effectively.
• Decision making: Comfortable exercising independent judgement and anticipating potential issues.
• Digital capabilities: Strong digital skills and confidence working with technical systems.
  

Quality & Compliance Antwerp Senior At MindCapture as consultant

About this application

This opportunity is offered through MindCapture as a consultancy role with strong day to day ownership. You will be placed on site with our client.

MindCapture supports you throughout your assignment with clear onboarding, regular follow up and access to learning opportunities. You will have a dedicated point of contact, transparent communication and support to help you deliver impact in a structured way.