Validation Engineer II, GMP

Tilburg - Netherlands

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Are you ready to advance your career with a world-class team At Thermo Fisher Scientific we seek an ambitious highly skilled Validation Engineer II for our validation department in Tilburg. You will ensure flawless execution of equipment utilities facilities qualification and process validation activities. You will work closely with technical development quality and production teams to meet world-class validation standards.

Job Description:

Proven hands-on experience in Commissioning & Qualification and Validation gained in a highly regulated environment within a pharmaceutical setting or equivalent
Demonstrates expertise in crafting new equipment changing processes growing production and successfully implementing new products
Co-drafts User Requirement Specifications (URS) with suppliers and the multi-disciplinary team
Drafts validation plans and performs implementation of protocols for C&Q/IQ/OQ/PQ related to equipment utility processes cleaning and computer validation including final reports and advice on periodical review frequencies
Ability to extract information from systems and generate Periodic Review Reports for critical equipment/utilities/processes including Continued Process Verification (CPV)
Provides validation technical support within other departments
Drafts reviews and amends procedures Validation Master Plan and other validation audited documents
Responsible for ensuring the validated status of all cGMP-critical automated process applications and quality systems
Remains abreast of current developments and regulations for the pharmaceutical industry
Acts as a validation SME for internal and external audits

Qualifications requirements:

Preference for candidates with a bachelors degree or equivalent experience in technology science or a related field and a willingness to learn. Prior experience in validation GMP or pharmaceutical manufacturing is required. This role offers an outstanding opportunity for learning and growth in various areas.

Personal:

Integrity Intensity Innovation and Involvement are core characteristics we expect of all members of our organization. If you enjoy leading change and working within a matrix organization to improve internal processes you will discover happiness in this role!

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAre you ready to advance your career with a world-class team At Thermo Fisher Scientific we seek an ambitious highly skilled Validation Engineer II for our validation department in Tilburg. You will ensure flawless execution...

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Are you ready to advance your career with a world-class team At Thermo Fisher Scientific we seek an ambitious highly skilled Validation Engineer II for our validation department in Tilburg. You will ensure flawless execution of equipment utilities facilities qualification and process validation activities. You will work closely with technical development quality and production teams to meet world-class validation standards.

Job Description:

Proven hands-on experience in Commissioning & Qualification and Validation gained in a highly regulated environment within a pharmaceutical setting or equivalent
Demonstrates expertise in crafting new equipment changing processes growing production and successfully implementing new products
Co-drafts User Requirement Specifications (URS) with suppliers and the multi-disciplinary team
Drafts validation plans and performs implementation of protocols for C&Q/IQ/OQ/PQ related to equipment utility processes cleaning and computer validation including final reports and advice on periodical review frequencies
Ability to extract information from systems and generate Periodic Review Reports for critical equipment/utilities/processes including Continued Process Verification (CPV)
Provides validation technical support within other departments
Drafts reviews and amends procedures Validation Master Plan and other validation audited documents
Responsible for ensuring the validated status of all cGMP-critical automated process applications and quality systems
Remains abreast of current developments and regulations for the pharmaceutical industry
Acts as a validation SME for internal and external audits

Qualifications requirements:

Preference for candidates with a bachelors degree or equivalent experience in technology science or a related field and a willingness to learn. Prior experience in validation GMP or pharmaceutical manufacturing is required. This role offers an outstanding opportunity for learning and growth in various areas.

Personal:

Integrity Intensity Innovation and Involvement are core characteristics we expect of all members of our organization. If you enjoy leading change and working within a matrix organization to improve internal processes you will discover happiness in this role!

Key Skills

Python
SOC
Debugging
C/C++
FDA Regulations
Minitab
Technical Writing
GAMP
OS Kernels
Perl
cGMP
Manufacturing

Apply Now

About Company

Thermo Fisher Scientific

Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more

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Validation Engineer II, GMP

Tilburg - Netherlands

Job Summary

Job Description:

Proven hands-on experience in Commissioning & Qualification and Validation gained in a highly regulated environment within a pharmaceutical setting or equivalent

Demonstrates expertise in crafting new equipment changing processes growing production and successfully implementing new products

Co-drafts User Requirement Specifications (URS) with suppliers and the multi-disciplinary team

Drafts validation plans and performs implementation of protocols for C&Q/IQ/OQ/PQ related to equipment utility processes cleaning and computer validation including final reports and advice on periodical review frequencies

Ability to extract information from systems and generate Periodic Review Reports for critical equipment/utilities/processes including Continued Process Verification (CPV)

Provides validation technical support within other departments

Drafts reviews and amends procedures Validation Master Plan and other validation audited documents

Responsible for ensuring the validated status of all cGMP-critical automated process applications and quality systems

Remains abreast of current developments and regulations for the pharmaceutical industry

Acts as a validation SME for internal and external audits

Qualifications requirements:

Personal:

Integrity Intensity Innovation and Involvement are core characteristics we expect of all members of our organization. If you enjoy leading change and working within a matrix organization to improve internal processes you will discover happiness in this role!

Job Description:

Proven hands-on experience in Commissioning & Qualification and Validation gained in a highly regulated environment within a pharmaceutical setting or equivalent

Demonstrates expertise in crafting new equipment changing processes growing production and successfully implementing new products

Co-drafts User Requirement Specifications (URS) with suppliers and the multi-disciplinary team

Drafts validation plans and performs implementation of protocols for C&Q/IQ/OQ/PQ related to equipment utility processes cleaning and computer validation including final reports and advice on periodical review frequencies

Ability to extract information from systems and generate Periodic Review Reports for critical equipment/utilities/processes including Continued Process Verification (CPV)

Provides validation technical support within other departments

Drafts reviews and amends procedures Validation Master Plan and other validation audited documents

Responsible for ensuring the validated status of all cGMP-critical automated process applications and quality systems

Remains abreast of current developments and regulations for the pharmaceutical industry

Acts as a validation SME for internal and external audits

Qualifications requirements:

Personal:

Integrity Intensity Innovation and Involvement are core characteristics we expect of all members of our organization. If you enjoy leading change and working within a matrix organization to improve internal processes you will discover happiness in this role!

Key Skills

About Company

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