Purpose of your Job
As a member of the Quality Control Team at Coriolis Pharma, you will play a key role in ensuring compliance and excellence across qualification and validation activities. You will collaborate with Qualification Experts and System Owners to ensure that equipment qualification and computerized system validation are executed according to GMP regulations and internal procedures. Acting as an interface between the GMP operative team, QA, and IT, you will define validation strategies, manage the validation lifecycle, and ensure proper documentation and traceability. In this role, you will help ensure that all qualification and validation tasks are completed efficiently, effectively, and in full compliance with regulatory standards.
Join Coriolis Pharma – a science-driven organization committed to quality and innovation!
Your Responsibility
Qualification & Validation Activities:
* Compile, review, and approve instrument qualification documentation.
* Release equipment for GMP use after successful completion of qualification projects in collaboration with QA.
* Compile, review, and approve risk assessments related to equipment qualification.
* Ensure that all qualification and validation documentation complies with internal SOPs and regulatory expectations.
* Support handling of (equipment-related) changes, deviations, CAPAs, SST failures, risk assessments, and OOS cases.
Analytical Method Validation & Lifecycle Management:
* Compile, review, and approve analytical method validation and verification documentation.
* Provide validation support for technology transfers and process changes.
* Collaborate with analytical teams during method validation projects to ensure robust and compliant outcomes.
* Support the GMP analytical team in defining validation strategies and managing the lifecycle of analytical methods.
* Assess validation needs during technology transfers or when introducing new processes.
Continuous Improvement & Compliance:
* Monitor industry trends and regulatory updates to refine validation strategies.
* Provide technical guidance and training on validation requirements and procedures.
* Support internal and external audits as well as authority inspections to ensure readiness and compliance.
What you need to succeed
* Master’s degree or equivalent in Biology, Chemistry, Pharmacy, or another field of natural science; PhD preferred
* Documented training in GMP regulations, Quality Management Systems, equipment qualification, and method validation
* Minimum 3 years of professional experience in equipment qualification and method validation within a regulated biopharmaceutical environment
* Strong knowledge of GMP and qualification/validation guidelines, with hands-on experience in compiling and reviewing qualification and validation protocols and reports
* Familiarity with risk assessment tools and compliance of computerized systems
* Excellent documentation skills with high attention to detail and accuracy
* Exceptional analytical and problem-solving abilities, combined with the capacity to manage multiple projects in a fast-paced, team-oriented setting
* Excellent communication and interpersonal skills, with fluency in English, both written and spoken
Why to join Coriolis?
Let’s formulate innovation together…
Our success & development is created by the people working together @Coriolis. We put People first! That’s why we have a growth mindset, and value personality, collaboration and community to create an empowering and inspiring working space with focus on quality and customers.
We would like to grow together with you!
Let’s continue building and creating the future now! Join our Team of currently around 200 employees. In a highly motivated and interdisciplinary team, we provide you with a great chance to increase your experience. We offer an attractive work space at the Martinsried site. Let’s make a difference together!
Coriolis Pharma is an equal opportunity employer and welcomes applications from all qualified individuals regardless of ethnicity, sex, citizenship or gender identity, color, disability, religion/belief, sexual orientation, marital status, age or individual preferences. Different backgrounds, experiences and ideas push us further and raise the bar.
Thank you for your interest! We look forward to receiving your application documents.
Please use our career portal exclusively for this purpose.
We would like to support you from the very beginning to shape your development possibilities here at Coriolis.
For questions or further information, please visit our website or contact us directly.
We are looking forward to your application!
Your Contact
Dominik Schwemmer
Senior Business Partner - Talent & Development
People, Organization & Culture Unit
Coriolis Pharma Research GmbH
Phone: +49 (0) 89 – 417760 - 0
Fraunhoferstraße 18 b, 82152 Martinsried
www.coriolis-pharma.com
About us
Coriolis Pharma is a global contract research and development organization (CRDO) and a premier partner for the development of liquid and lyophilized drug products, analytical services, and manufacturing services across a vast array of therapeutic modalities, including biologics, gene and cell therapies and vaccines.
Our scientists design and execute platform and custom services to accelerate and derisk our clients’ programs right from the start and throughout the entire product lifecycle.
Our company culture is based on diversity, teamwork and open and appreciative communication. That's why wonderful people from over 36 nations around the world work together successfully at Coriolis.
Our headquarters are located in Martinsried near Munich, Germany. An additional project management and business development team in the United States enables our US clients to work seamlessly with our German offices.
What motivates us? Our motivation is to improve the quality of life for humankind by enabling the development of innovative drugs through outstanding biopharmaceutical services from preclinical to commercialization