CSV Engineer
Vilnius, Lithuania, 00100
We Are Teva
The opportunity
The CSV Engineer will play a pivotal role in assuring the quality and reliability of computerized systems that support our pharmaceutical processes. This role is central to ensuring that our systems meet regulatory and industry standards, ensuring that patient safety and product quality are uncompromised.
How You’ll Spend Your Day
- Lead and execute validation efforts for computerized systems to ensure compliance with regulatory standards, including FDA 21 CFR Part 11, EU Annex 11, and other relevant guidelines.
- Develop, review, and approve validation documentation such as Validation Plans, Risk Assessments, Requirement Specifications, Test Protocols, and Validation Reports.
- Conduct periodic reviews of validated systems to ensure ongoing compliance and revalidate as necessary.
- Collaborate with cross-functional teams, including IT, QA, and Operations, to ensure aligned validation strategies and seamless project execution.
- Investigate and address discrepancies or anomalies during validation activities.
- Stay updated with emerging regulations and best practices in computerized system validation.
- Conduct training for relevant stakeholders on CSV principles and best practices.
- Support internal and external audits by providing expertise and documentation related to computerized system validations.
Your Skills and Experience
- Technical or scientific education (preferably in the field of Engineering, IT, Life Science or similar). You can be last year student.
- Excellent computer skills (MS Office and general windows applications)
- Able to work independently, systematize and summarize information in written and verbal format
- Strong analytical, problem-solving, and organizational skills.
- Effective communication skills, both written and verbal.
- Familiarity with various software development lifecycles, engineering solutions, equipment, processes.
- Good English and Lithuanian language
How We’ll Take Care of You
- Salary range of 2 200 – 2 500 Euro gross monthly
- Benefits package: health and accident insurance, additional health and vacation days (for worked years)
- Highly professional team and organizational culture with strong values
- Personal and professional development within the company
- Employee rewards and recognition programs, events and social activities
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment