Computer Software Validation Specialist (m|f|d)
Computer Software Validation Specialist (m|f|d)
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1 Vacancy
Job Description
In this role youll be a key member of our Qualification & Validation Team specializing in the validation of computerized systems. Your work will ensure our systems meet the highest quality standardsplaying a vital part in our mission to advance cancer treatment and make a lasting difference in patients lives.
- Youll plan coordinate and execute CSV tasks in manufacturing quality control and logistics at our GMP-certified site in Bergisch Gladbach.
- From URS and risk assessments to IQ/OQ protocols reports and SOPsyoull handle all documentation with precision and care.
- Youll guide departments through validation projects propose effective solutions and oversee their implementation.
- As a GxP expert youll be involved in deviation handling CAPA change control and continuously improve validation-related procedures.
- Youll work closely with internal stakeholders (IT QA QC Manufacturing) and external vendors and deliver training based on your activities.
Qualifications :
- You have a degree in life sciences bioinformatics or engineering and have extensive professional experience in the validation of computerised systems (CSV) as well as solid knowledge of data integrity.
- You are familiar with the requirements of regulated environments in the pharmaceutical industry and are familiar with standards such as GMP and FDA guidelines.
- You love bringing order to complex processes enjoy working in a structured manner and develop creative approaches to continuously improve processes.
- You are a true team player with strong communication skills whether interacting with internal teams customers or external suppliers.
- You enjoy working in an interdisciplinary and international environment speak fluent English (German is a plus) and feel comfortable in collaborative cross-functional teams.
Additional Information :
What we offer
- Diversity: International teams and cross-border intercultural communication
- Room for creativity: Its the most clever solution that we always strive for
- Health & Sport: Corporate sports activities and health provision
- Miltenyi University: A clever mind never stops learning take advantage of our inhouse Training Academy
- Corporate benefits: Employee events 30 days of vacation (e)-bike leasing company pension plan and many other offers
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.
Contact us
If you are passionate about the purpose of your code and enjoy working in a supportive team culture then please do not hesitate to join us in our great vision and make a real difference to peoples lives.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
