Cleaning Validation Engineer

Elmea Consulting; Brussel Hoofdstad; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Elmea Consulting is seeking a highly motivated Cleaning Validation Engineer to join our regulated pharmaceutical team. You will work with site teams to develop, improve and harmonise Cleaning Validation practices globally.

The role focuses on regulatory compliance, patient safety and continuous improvement, combining hands-on validation work with proactive collaboration across Quality, Manufacturing and Engineering.

Qualifications

• Proven experience in Cleaning Validation within pharmaceutical, biotech or other highly regulated industry
• Strong knowledge of GMP requirements and Cleaning Validation regulations

Responsabilités

• Develop and harmonise Cleaning Validation practices across units
• Define cleaning strategies, MACO/HBEL/PDE criteria
• Prepare and review Cleaning Validation protocols and reports
• Ensure GMP compliance and regulatory readiness
• Support deviations, investigations and CAPA
• Coach colleagues on technical cleaning validation concepts

Connaissances

Cleaning Validation

GMP knowledge

QA/Regulatory

Risk management

Cross-functional collaboration

Data integrity

CAPA investigations

Analytical thinking

Description du poste

Are you ready to take your career to the next level?

Do you thrive in environments that challenge and inspire you?

Would you like to grow within a team that values both excellence and enjoyment at work?

Elmea Consulting is an international management consulting group with offices in France, Luxembourg, Belgium, The Netherlands, Switzerland, Spain, Singapore, Portugal, and Italy.

We’ve grown into a team of 450+ talented professionals across 10 offices worldwide, partnering with leading organizations in Pharmaceutical, Life Sciences, Retail, and Energy - Sectors, to drive transformation and deliver lasting impact.

At Elmea, you’ll find more than just a job. You’ll join a community of ambitious consultants who share a passion for growth, innovation, and teamwork. Together, we create an environment where you can develop your skills, take on new challenges, and truly make a difference.

What Will You Do?

At Elmea Consulting, we believe that our growth starts with our people. When our consultants thrive, so do our clients. Motivated, curious, and passionate professionals make a real impact, not only on their own careers but also on the success of the organizations they support.

We’re looking for individuals who embody our values and help us foster strong, trust-based relationships with both our clients and our teams across the globe. Our success is built on the talent, collaboration, and commitment of our people and we’re now looking for a Cleaning Validation Engineer to join our journey.

Are you an experienced Cleaning Validation Engineer looking for a new challenge in a highly regulated pharmaceutical environment?

We are looking for a Cleaning Validation Consultant to support a major pharmaceutical organisation in strengthening its Cleaning Validation expertise, ensuring patient safety, regulatory compliance and sustainable processes across both routine operations and strategic projects.

Your Role

As a Cleaning Validation Engineer, you will act as a subject matter expert and work closely with site teams and cross-functional stakeholders to develop, improve and harmonise Cleaning Validation practices.

You will combine hands-on technical expertise with a strong focus on continuous improvement, regulatory compliance and knowledge sharing.

Your Responsibilities

Cleaning Validation & Process Development

• Develop and continuously improve science- and risk-based cleaning strategies, including worst-case assessment, grouping and bracketing approaches.
• Support the development and optimisation of cleaning processes and methods.
• Define and justify cleaning acceptance criteria, including MACO, HBEL and PDE.
• Author, review and support the approval of Cleaning Validation protocols and reports.
• Ensure Cleaning Validation procedures remain aligned with current GMP and regulatory requirements.
• Provide expert support for deviations, investigations, root cause analysis and CAPA.

Quality & Regulatory Excellence

• Ensure Cleaning Validation activities remain inspection-ready and compliant with global regulatory expectations.
• Maintain an active watch on regulatory developments and industry best practices.
• Ensure the quality, traceability and data integrity of Cleaning Validation documentation.
• Proactively identify and escape risks impacting product quality and patient safety.

Collaboration & Continuous Improvement

• Drive the harmonisation and standardisation of Cleaning Validation practices across different Business Units.
• Facilitate knowledge sharing and promote best practices across teams.
• Collaborate with Quality, Manufacturing, Engineering and other key stakeholders.
• Contribute to continuous improvement, digitalisation and broader Qualification & Validation initiatives.
• Support capability building by coaching and sharing technical expertise with colleagues.

Your Profile

• Proven experience in Cleaning Validation within the pharmaceutical, biotech or other highly regulated industry.
• Strong knowledge of GMP requirements and Cleaning Validation regulations.
• Hands-on experience with:
• Cleaning Validation strategies
• Worst-case assessment
• Grouping and bracketing
• MACO / HBEL / PDE
• Cleaning Validation protocols and reports
• Deviations, investigations and CAPA
• Strong understanding of risk-based approaches and Quality Risk Management.
• Experience working in a cross-functional and international environment is a strong asset.
• Comfortable combining technical expertise with a pragmatic, hands-on approach.

Who Are You?

You are a trusted expert who enjoys working closely with operational teams while maintaining a strong focus on quality and compliance.

You are:

Proactive and solution-oriented

Analytical and quality-focused

Hands-on and pragmatic

Comfortable challenging existing practices

A strong team player and communicator

Passionate about knowledge sharing and continuous improvement

Able to influence stakeholders without relying on formal authority

If you are looking for a challenging mission where your Cleaning Validation expertise can directly contribute to patient safety, operational excellence and regulatory compliance, we would be happy to hear from you!