Senior CSV Engineer
Q-Med AB / Kemiingenjörsjobb / Uppsala
2025-05-13
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Do you enjoy making sure systems work as they should and want to contribute to high-quality, compliant solutions?
At Galderma, we're growing our engineering team in Uppsala and are looking for a Computerized System Validation (CSV) Engineer to support both daily operations and long-term projects. With new systems being implemented and existing ones evolving, you'll have the opportunity to join us at a time of exciting development and change, with the opportunity to contribute from the start. Galderma is the world's largest independent dermatology company, offering a science-based portfolio across aesthetics, skincare, and therapeutic solutions in close collaboration with healthcare professionals.
The role
You'll be part of a collaborative engineering team that works closely with colleagues in automation, commissioning, qualification, and quality. The team ensures that hardware installations, software validation, and data management are all compliant, reliable, and well-documented. As a CSV Engineer, your focus will be on the validation and qualification of computerized systems connected to Facility, Utility, and Manufacturing areas. You'll ensure systems are implemented correctly, perform as intended, and meet the relevant regulatory requirements such as GxP and GAMP5.
In this role, you will:
* Function as the SME (subject matter expert) regarding Computerized System Validation and provide guidance to engineers within the organizaition and project teams.
* Plan, write, and execute validation protocols (IQ, OQ, PQ) for computerized systems
* Review system design and functionality to ensure compliance with regulatory requirements and industry standards.
* Perform hands-on testing of systems and interfaces
* Ensure that all OT systems and processes meet, and can be used as intended, according to the required standards and regulations.
Who are you?
To thrive as a CSV Engineer at Galderma, you're someone who values collaboration and enjoys being part of a team working toward shared goals. You bring a positive mindset, are flexible in how you work, and take a structured approach to tasks. You're naturally curious about how systems operate, especially within Operational Technology (OT), and you like making sure they run smoothly, communicate correctly, and meet all the right standards.
We believe you also bring:
* At least 5 years of experience with Computerized System Validation (CSV), ideally from the pharmaceutical or medical device industry, where quality and compliance are part of everyday life.
* Familiarity with GxP environments and frameworks like GAMP5
* Experience creating and executing Plans, Protocols, Test Scripts and Reports as they relate to Qualification and Validation of assigned Computerized systems associated with Facility, Utility and Manufacturing GxP systems throughout their lifecycle.
* Proficency with all the phases of SDLC (System Development Life Cycle), STLC (system testing life cycl) processes, Validation methologies and Concepts of Qualification Documents/ Protocols.
* Fluency in both Swedish and English
What we offer in return
You will be working for an organisation that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
As Galderma's Global Center of Excellence for Aesthetics we have in Uppsala a unique edge as we have on our site the whole product chain from development to production and marketing. Here our nearly 600 employees work on our world leading brands such as Restylane, Azzalure and Sculptra.
We are offering you the opportunity to work in an exciting, international environment where both professional and personal development is encouraged. We are based in modern offices and located just by the river (Fyrisån) in Uppsala only a 10 minute bike ride from Uppsala Central Station.
Next steps
We welcome your application via our company website CAREERS | Galderma. Apply as soon as the selection process is ongoing.
* If your profile is a match, we will invite you for a first conversation with the recruiter.
* The next step is an interview with the hiring manager
* The final step is a panel conversation with the extended team
Our people make a difference
At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2025-05-23
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "JR014076".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Q-Med AB (org.nr 556258-6882)
Arbetsplats Galderma
Kontakt Galderma
meysa.mohamed@galderma.com Jobbnummer 9336346