Senior CSV Engineer
Senior CSV Engineer
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Job Description
Galderma is the emerging pure-play dermatology category leader present in approximately 90 countries. We deliver an innovative science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981 we have dedicated our focus and passion to the human bodys largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives we are advancing dermatology for every skin story.
We look for people who focus on getting results embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all they must be passionate about doing something meaningful for consumers patients and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company we embrace diversity and respect the dignity privacy and personal rights of every employee.
At Galderma we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled direct impact.
CSV Engineer
Do you enjoy making sure systems work as they should and want to contribute to high-quality compliant solutions
At Galderma were 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 youll 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 worlds largest independent dermatology company offering a science-based portfolio across aesthetics skincare and therapeutic solutions in close collaboration with healthcare professionals.
The role
Youll 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. Youll 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 youre 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. Youre 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 Galdermas 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 (Fyrisn) 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 youll 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.
Required Experience:
Senior IC
Employment Type
Full-Time
