Cleaning Validation Engineer - Life Sciences (Flanders)

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 company in the fields of Life Sciences, Engineering and IT in which our people and clients are central.

In our open and adaptable organization, we get the best out of our ambitious employees enabling them to perform optimally. We do this by offering them the most challenging projects, but also to continuously acquire new expertise to boost their careers. This can be done with the help of our ALTEN Academy, but also through our knowledge sharing events.

All employees together form a large network of expertise, even at an international level. In this way we offer optimal growth to our consultants and the best solutions for our customers.

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. Experience with autoclave qualification and a good understanding of CQV activities are considered strong assets.

Main Responsibilities

Cleaning Validation

• 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.

Your Profile

Education

• Master's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biotechnology or a related scientific discipline.

Experience

• 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.

Technical Skills

• Cleaning Validation
• GMP / cGMP
• Cleaning Process Design
• Validation Lifecycle Management
• Deviations, CAPA and Change Control
• Autoclave Qualification
• IQ / OQ / PQ

What ALTEN has to offer

• A permanent contract
• A salary package in line with your experience and extra benefits (company car, meal vouchers, recovery days, insurances)
• The possibility to join a great team and be part of the success story of an international group