Life sciences Computer System Validation Engineer
Life sciences Computer System Validation Engineer
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Job Description
As a quality and compliance expert you will be responsible for ensuring that GxP systems and processes adhere to the applicable regulatory requirements throughout the entire system lifecycle. Therefore you stay up to date about evolving regulations from authorities such as the EMA and FDA and industry standards like GAMP and ISO. Depending on your role and expertise you may be asked to provide Quality & Compliance support during audits and inspections or to join a Sopra Steria validation service team.
As a trusted Computerized System Validation (CSV) Engineer you play a key role in the validation process of the computerized systems used by our clients in the Life Sciences sector. More specifically your mission is to ensure the quality and regulatory compliance of GxP systems throughout their entire life cycle and across all GxP areas (GLP GCP GMP GDP GPvP). Systems in scope can include sitespecific lab instruments (e.g. HPLC software) and production equipment (e.g. capsule filling machine) but also globally used web applications Clinical Trial Management Systems complex Manufacturing Execution Systems SAP systems medical devices etc
Qualifications :
Were seeking passionate colleagues who are eager to push the boundaries in digital transformation and technology consulting. At Sopra Steria youll have the opportunity to grow your skills in a constructive collaborative team environment working on impactful projects that drive change for our clients. If you thrive on challenge and meet (most of) the qualifications below we look forward to your application!
- Proven CSV experience in multiple projects or strong interest in CSV
- Strong affinity with IT
- Analytical and pragmatic thinking skills
- Strong prioritization and planning skills
- Strong sense of responsibility and accountability
- A positive solutiondriven mindset
- Excellent written and oral communication skills in Dutch and English
- Basic knowledge of IT infrastructure qualification
- A team player but also able to work independently
- Familiar with applicable regulatory standards and guidelines (21CFR Part 11 EU Annex 11 GDPR GAMP5 ISO 9001...) and concepts such as QMS CAPAs Data Integrity... .
- Familiar with applying validation methodologies (Waterfall Agile) within a GxP environment.
Additional Information :
Our employees are known for making bold choices and delivering results. Work among highlevel professionals at the forefront of corporate software solutions and innovation at Europes Leading Digital Service Provider.
We offer a generous employee benefits package that includes:
- Project opportunities with top companies both nationally and internationally
- A career with focus on knowledge and innovation in the exciting word of Life Sciences
- Experienced colleagues open to share their experience and expertise
- A variety of perks such as mobility options (including a company car) insurance coverage meal vouchers ecocheques and more.
- Continuous learning opportunities through the Sopra Steria Academy to support your career development.
- The opportunity to connect with fellow Sopra Steria colleagues at various team events.
Want to know what happens next
People are the cornerstone of our success. Thats why we aspire to be bolder together. Our goal is to build highfunctioning teams and healthy team environments that inspire and help each other to deliver excellence for each of our customers.
Excited about this job opportunity Ready to shape the world with us Great! We are looking forward to your application!
Sopra Steria is an equal opportunity employer. All qualified applicants will be considered for employment without regard to age ancestry nationality color family or medical leave gender identity or expression genetic information immigration status marital status medical condition national origin physical or mental disability political affiliation protected veteran or military status race ethnicity religion gender (including pregnancy) sexual orientation or any other characteristic protected by applicable local laws regulations and ordinances. We foster a work environment that is inclusive and respectful of all differences.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
