Computerized System Validation Manager (m|f|d)

Bergisch Gladbach - Germany

Monthly Salary: Not Disclosed

Posted on: 9 hours ago

Vacancies: 1 Vacancy

Job Summary

As a Computerized System Validation Manager you provide quality assurance oversight and support for Miltenyi Biomedicines validation and qualification activities with a particular focus on Computerized System Validation (CSV). You ensure that these activities comply with applicable regulatory requirements internal quality standards and data integrity this role you collaborate closely with cross-functional teams to align validation efforts with Miltenyi Biomedicines Quality Management System (QMS) and contribute to the continuous improvement of QA processes and documentation.

You execute and oversee validation and qualification activities (including CSV) and ensure compliance with GxP data integrity standards and our QMS.
You review and approve validation documentation such as plans protocols reports and risk assessments to ensure accuracy and regulatory alignment.
You develop and maintain QA documentationincluding SOPs work instructions templates and toolssupporting validation qualification and change control.
You guide and train our teams on QA expectations related to validation qualification and change management fostering strong quality awareness.
You provide QA review and approval within our change management process ensuring proper assessment and control of changes impacting validated systems.
You ensure structured documentation controlled access and reliable version management while contributing to additional QA tasks as needed.

Qualifications :

You hold a university degree or have equivalent professional experience in a relevant field ideally in biosciences pharmacy or engineering.
You bring experience in validation and qualification within a GxP-regulated environment preferably in the pharmaceutical or biotechnology industry.
You have a solid understanding of CSV GxP and data integrity principles and are familiar with EU and FDA regulatory expectations.
You are experienced in reviewing technical documentation and applying quality standards in a structured and detail-oriented manner.
You are confident working with digital tools and platforms such as VEEVA (Safety RIM Clinical. Experience with Ennov is a plus.
You communicate clearly and fluently in English (C1) and collaborate effectively across departments.

Additional Information :

What we offer

Working with free and self-determined time management also mobile working
An intercultural environment characterized by diversity and flat hierarchies
Freedom to contribute creatively and play an active role in shaping the company
Individual further training in our Miltenyi University as the core of the Miltenyi DNA
30 days of vacation discounted ticket to Germany (e)-bike leasing capital-forming benefits company pension plan disability insurance canteen and much more.

Diversity is the bedrock of our creativity

Our mission: To innovate treatments and technologies and tackle the worlds most serious health challenges. And thats why we connect the dots across various disciplines linking different perspectives skills and abilities.

You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender sexual identity age ethnicity religion or disability.

Become part of our team and focus on pushing the borders of medicine.

We look forward to your application

If you want to work in an open creative and supportive team this is the place for you. We look forward to receiving your application along with your salary expectations and availability.

Remote Work :

Employment Type :

Full-time

You execute and oversee validation and qualification activities (including CSV) and ensure compliance with GxP data integrity standards and our QMS.
You review and approve validation documentation such as plans protocols reports and risk assessments to ensure accuracy and regulatory alignment.
You develop and maintain QA documentationincluding SOPs work instructions templates and toolssupporting validation qualification and change control.
You guide and train our teams on QA expectations related to validation qualification and change management fostering strong quality awareness.
You provide QA review and approval within our change management process ensuring proper assessment and control of changes impacting validated systems.
You ensure structured documentation controlled access and reliable version management while contributing to additional QA tasks as needed.

Qualifications :

You hold a university degree or have equivalent professional experience in a relevant field ideally in biosciences pharmacy or engineering.
You bring experience in validation and qualification within a GxP-regulated environment preferably in the pharmaceutical or biotechnology industry.
You have a solid understanding of CSV GxP and data integrity principles and are familiar with EU and FDA regulatory expectations.
You are experienced in reviewing technical documentation and applying quality standards in a structured and detail-oriented manner.
You are confident working with digital tools and platforms such as VEEVA (Safety RIM Clinical. Experience with Ennov is a plus.
You communicate clearly and fluently in English (C1) and collaborate effectively across departments.

Additional Information :

What we offer

Working with free and self-determined time management also mobile working
An intercultural environment characterized by diversity and flat hierarchies
Freedom to contribute creatively and play an active role in shaping the company
Individual further training in our Miltenyi University as the core of the Miltenyi DNA
30 days of vacation discounted ticket to Germany (e)-bike leasing capital-forming benefits company pension plan disability insurance canteen and much more.

Diversity is the bedrock of our creativity

You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender sexual identity age ethnicity religion or disability.

Become part of our team and focus on pushing the borders of medicine.

We look forward to your application

If you want to work in an open creative and supportive team this is the place for you. We look forward to receiving your application along with your salary expectations and availability.

Remote Work :

Employment Type :

Full-time

Key Skills

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

Apply Now

About Company

Miltenyi Biotec

For over 30 years, Miltenyi Biotec has been a major provider of products and services that drive biomedical research and boost cell and gene therapy. More than 4,700 employees in 23 countries combine excellence in research with innovative products to create cutting-edge solutions that ... View more

View Profile View Profile

AI AutoApply

Apply to 100+ jobs with one click