Cleaning Validation Engineer
Il y a 10 heures
Antwerp, Flanders, Belgique
ALTEN
Temps plein
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Gratuit avec email ou Google
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 Risk Assessments Cleaning Process Design Validation Lifecycle Management Deviations, CAPA and Change Control Autoclave Qualification IQ / OQ / PQ Sterilisation Processes CQV Principles
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
Apply now and be a part of our amazing journey. We believe in growing together
We are looking forward to getting to know you and your ambitions
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 Risk Assessments Cleaning Process Design Validation Lifecycle Management Deviations, CAPA and Change Control Autoclave Qualification IQ / OQ / PQ Sterilisation Processes CQV Principles
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
Apply now and be a part of our amazing journey. We believe in growing together
We are looking forward to getting to know you and your ambitions