Qualification Validation Expert (m|f|d) at Miltenyi Biotec

Bergisch Gladbach, North Rhine-Westphalia, Germany -

Full Time

Start Date

Immediate

Expiry Date

08 Oct, 26

Salary

0.0

Posted On

10 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Qualification, Validation, GMP Compliance, IQ/OQ/PQ, Lifecycle Management, Risk Assessment, SOP Documentation, CAPA, Change Control, Biotechnology, Life Sciences, English Fluency

Industry

Biotechnology Research

Description

Company Description For more than 35 years, we have been developing cutting-edge science and technology to empower biomedical research and personalized medicine. We combine excellence from more than 60 disciplines in natural sciences, engineering, and informatics to make a significant contribution to biomedical sciences. We encourage a creative working environment driven by pioneering spirit – to seek new horizons – boldly envisioning the future and turning it into reality. Today, more than 4,800 experts from over 75 countries contribute to our sustainable success. Job Description As a member of our Cell Factory Team, you will participate at our transition from our clinical to our commercial manufacturing of our cell and gene therapies, supporting the move to electronic records and witnessing this significant transformation first-hand. You will help ensure that our devices and systems in our cell factory comply with recognized Good Manufacturing Practice (GMP) standards, thereby directly impacting the delivery of personalized medicine to patients. You will support qualification, validation and lifecycle management activities for systems used across production, quality control and logistics at our GMP manufacturing site in Bergisch Gladbach. With a strong focus on compliance and documentation, you will execute and document IQ/OQ/PQ activities for manufacturing equipment, utilities and laboratory systems, ensuring their qualified state within a GMP-regulated environment. You will prepare, maintain and update qualification and validation documentation, including URS, risk assessments, test plans, reports and SOPs. Working closely with experienced colleagues, you will contribute to qualification and validation projects and support the implementation of compliant and practical solutions. You will assist with GxP-related activities such as deviations, CAPAs and change controls while supporting continuous process improvements. Qualifications You hold a degree in Life Sciences, Biotechnology or a related discipline. Alternatively, you are qualified as a Biological Technical Assistant (BTA) or hold a comparable qualification. You have gained initial experience in qualification, validation, commissioning or supporting IQ/OQ/PQ activities within a GMP-regulated environment. Experience with GMP requirements as well as in the pharmaceutical, biotechnology, medical device or other regulated industries would be advantageous. You are organized, work in a structured manner and enjoy supporting process improvements in a dynamic environment. As a team player, you value open communication and collaboration with colleagues, customers and external partners. You are fluent in English and feel comfortable working in cross-functional and international teams. Additional Information What we offer Flexible and remote work: Enable time management on your terms Diversity: International teams and cross-border intercultural communication Room for creativity: It’s the most clever solution that we always strive for Health & Sport: We offer a wide range of corporate sports activities and health provision Miltenyi University: A clever mind never stops learning, take advantage of our in-house Training Academy Diversity is the bedrock of our creativity. Our mission: To innovate treatments and technologies and tackle the world’s most serious health challenges. And that’s 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. Contact us If you have the skills and qualifications for this position, please use the link to send us your details (application letter, curriculum vitae, references and certificates). Please give us some idea of when you can start and the kind of salary you are looking for. Department: Manufacturing Location: Bergisch Gladbach Functional Area: Production and Manufacturing Company: Miltenyi Biotec B.V. & Co. KG

Responsibilities

The role involves executing and documenting qualification and validation activities (IQ/OQ/PQ) for manufacturing equipment and laboratory systems in a GMP environment. You will also manage validation documentation, including URS and risk assessments, while supporting continuous process improvements.