Cleaning Validation Engineer

Geel

Contract

Negotiable

Quality

CR/608924_1788766519

Location: Geel, Belgium

Contract duration: 12 months +

Overview

An exciting opportunity is available for an experienced Senior Quality Engineer specialising in Cleaning Validation to join a leading pharmaceutical manufacturing site in Geel, Belgium. The role supports quality oversight activities across cleaning validation programmes, ensuring compliance with global pharmaceutical regulations and internal quality standards.

The successful candidate will act as a subject matter expert, partnering with manufacturing, MSAT, validation, and quality teams to drive compliance, continuous improvement, and operational excellence.

Key Responsibilities

Provide quality oversight for all cleaning validation activities across the site.
Ensure compliance with applicable GMP regulations, industry guidelines, and company procedures.
Support and influence strategic improvements within the site's cleaning validation programme.
Act as QA representative for compliance improvement initiatives and action plans.
Review and approve:
- SOPs
- Validation protocols
- Validation reports
- Risk assessments
- Change controls
- Deviations
- Investigation documentation
- Trend analyses
Collaborate with cross-functional teams on the implementation of new cleaning validation approaches and technologies.
Provide QA guidance during project execution to ensure cGMP requirements are incorporated from project initiation through implementation.
Participate in multidisciplinary teams to deliver site quality and compliance objectives.
Drive risk-based decision making while balancing business and quality requirements.

Requirements

Master's degree in a scientific or engineering discipline, or equivalent industry experience.
Extensive pharmaceutical or chemical industry experience, ideally 10+ years.
Strong expertise in cleaning validation and validation lifecycle management.
In-depth knowledge of:
- EU GMP
- ICH Q7
- ICH Q9
- 21 CFR Part 211
Experience reviewing and approving GMP documentation.
Excellent stakeholder management and communication skills.
Ability to work across multiple functions and influence without direct authority.
Strong analytical skills and comfort working within fast-paced environments.
Fluent written and spoken English and Dutch.

Ideal Candidate Profile

An experienced QA professional with a strong background in GMP-regulated pharmaceutical manufacturing and cleaning validation. The ideal candidate combines deep technical expertise with a pragmatic quality mindset, enabling them to provide effective oversight while partnering with operational teams. They are comfortable making risk-based decisions, leading compliance initiatives, and influencing stakeholders across validation, manufacturing, engineering, and quality functions. Dutch and English language capabilities are essential.

FAQs

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