CSV Engineer
Rottapharm Limited
Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high‑quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.
We have been included on a number of award lists that demonstrate the impact we are making.
Our global portfolio includes best‑in‑class, iconic brand‑name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
Key responsibilities for this role include:
Manage, co‑ordinate, develop and execute the validation deliverables for new Information System (IS) projects.
Support and co‑ordinate the qualification and validation processes.
Support activities include, but are not limited to, the preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPs and Change controls.
Responsible for ensuring that computerized systems are in full compliance with regulatory requirements, company policies and procedures. This individual will provide compliance leadership, direction and execution in Computer System Validation for new projects.
Support the resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11) and participate in required project teams.
Responsible for ensuring that the Technical Services Manager is consulted on all validation deliverables.
Conduct validation training with project team communicating deliverables, procedures and methods.
The minimum qualifications for this role are:
Looking for a minimum of a Bachelor’s degree with a minimum of 3 years of related CSV industry experience (Pharma/Biotech).
Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required.
Strong knowledge of computerized system development life cycle approach is required.
The ability to work and make decisions independently and have the flexibility to adapt to changing priorities is required.
Strong leadership skills and the ability to work in cross‑functional team environments, as well as independently.
Excellent PC skills with proficiency in automation systems.
Experience of coordination of Quality documentation and in particular, qualification/validation documentation.
Strong written and verbal communication skills are required.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
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