Cleaning Validation Engineer - GMP, Autoclave & CQV

ALTEN; Vlaanderen; Sur place; EUR 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

A permanent contract

A salary package in line with your经验

The possibility to join a great team

international group

Résumé du poste

ALTEN Belgium is a leading consultancy in Life Sciences, Engineering and IT, focused on our people and clients. We offer challenging projects and career growth through the ALTEN Academy and knowledge sharing events.

We are currently looking for an Cleaning Validation Engineer at one of our clients. The ideal candidate has a strong background in Cleaning Validation, including strategy development, protocol execution, investigation management and lifecycle support.

Qualifications

• Master's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biotechnology or a related scientific discipline.
• Minimum 3 years of experience in Cleaning Validation within the pharmaceutical or biotechnology industry.
• Demonstrated experience writing and executing Cleaning Validation protocols and reports.
• Experience managing deviations, CAPAs and change controls linked to validation activities.
• Experience with autoclave qualification and sterilisation processes.
• Knowledge of CQV methodologies and qualification lifecycle activities.
• Experience in sterile manufacturing environments is a strong asset.

Responsabilités

• Lead Cleaning Validation activities for manufacturing equipment and production processes.
• Define Cleaning Validation strategies based on risk assessments and regulatory requirements.
• Develop, execute and review validation protocols and reports.
• Establish cleaning acceptance criteria and sampling plans.
• Perform residue and recoverability assessments.
• Manage worst-case product and equipment matrix approaches.
• Support routine monitoring, continued verification and revalidation activities.
• Investigate deviations, non-conformities and out-of-specification results related to cleaning processes.
• Support Change Controls, CAPAs and audit/inspection readiness activities.
• Ensure compliance with GMP, FDA and EMA expectations.

Connaissances

Cleaning Validation

GMP / cGMP

Cleaning Process Design

Validation Lifecycle Management

Deviations, CAPA and Change Control

Autoclave Qualification

IQ / OQ / PQ

CQV methodologies

Formation

Master's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biotechnology or related

Description du poste

ALTEN Belgium is a leading consultancy in Life Sciences, Engineering and IT, focused on our people and clients. We offer challenging projects and career growth through the ALTEN Academy and knowledge sharing events.

We are currently looking for an Cleaning Validation Engineer at one of our clients. The ideal candidate has a strong background in Cleaning Validation, including strategy development, protocol execution, investigation management and lifecycle support.