Cleaning Validation Engineer

EPM Scientific; Geel; Sur place; EUR 85 000 - 120 000; Plein temps

Résumé du poste

EPM Scientific Geel, Belgium is seeking an experienced Senior Quality Engineer specializing in Cleaning Validation to join a leading pharmaceutical manufacturing site.

The role provides quality oversight across cleaning validation programs and partners with manufacturing, MSAT, validation, and quality teams to drive compliance and continuous improvement.

Qualifications

• Master's degree in a scientific or engineering discipline or equivalent experience.
• 10+ years of pharmaceutical or chemical industry experience.
• Expert in cleaning validation and lifecycle management.
• Knowledge of EU GMP, ICH Q7, ICH Q9, and 21 CFR Part 211.
• Fluent in English and Dutch, both written and spoken.

Responsabilités

• Provide quality oversight for cleaning validation activities across the site.
• Ensure compliance with GMP regulations, guidelines, and procedures.
• Support and influence improvements within the cleaning validation programme.
• Act as QA representative for compliance initiatives and action plans.
• Review and approve SOPs, validation protocols, reports, risk assessments, change controls, deviations, investigations, and trend analyses.

Connaissances

Cleaning validation

Quality oversight

GMP compliance

Stakeholder management

Regulatory knowledge

Validation lifecycle management

Cross-functional collaboration

English and Dutch language proficiency

Formation

Master's degree in science/engineering

Description du poste

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.