We're Hiring!
CSV Associate

Working at Scilife means being part of a fast-paced, collaborative, and supportive environment. In this role, you will focus on delivering high-quality support in computer system validation (CSV) and Quality Assurance (QA) tasks. You will be deeply involved in creating and reviewing validation documentation, ensuring compliance with global regulatory standards such as GAMP5, HIPAA, and 21 CFR Part 11.

You’ll collaborate across various process teams, contribute to continuous improvement initiatives, and participate in audits and functional testing activities. Expect to work independently and take ownership of your tasks while also being part of a friendly and globally distributed team that values clear communication, autonomy, and shared goals.

Your responsibilities:

• Provide desired support and own related to computer system validation and Quality Assurance tasks such Change Control, CAPA, Deviations etc.
• Author or Review as contributor to the accuracy and completeness of software validation deliverables created by other process teams (e.g., User Requirements Specification, Functional Specifications, Risk Assessments, Traceability Matrix, Configuration Specifications, IQ, OQ, PQ, etc.).
• As a CSV Associate you are likely to combine tasks such as proposing and implementing improvements with reviewing, maintaining, and updating key documentation in accordance with current regulatory requirements.
• Documentation – writing, maintaining, reviewing and updating validation documentation, and approving validation SOPs as required;
• Provide desired support related to computer system validation tasks
• Review the accuracy and completeness of software validation deliverables created by other process teams (e.g., Requirements Specification, IQ, OQ, PQ).
• Participate in the functional testing of the product.
• Involved in the preparation and checking of validation-related protocols.
• Ensures business requirements are met in the final solution.
• Some other responsibilities as assigned

What you will need:

• Detailed technical understanding of computer system validation and infrastructure qualification, including the application of risk managed approaches.
• Minimum 3-5 years regulated industry experience and regulatory understanding.
• Well conversant with HIPAA, GAMP5, 21 CFR Part 11 and Eudralex volume 4 Annexure 11 requirements for CSV & GxP practices.
• Expert at managing complexity and multiple work streams in changing circumstances.
• Excellent communication skills with the ability to effectively convey compliance requirements at all levels.
• Experience in the utilisation of risk analysis tools such as FMEA, FTA, etc.
• Experience in hosting/defending external audits and regulatory inspections.
• Experience in electronic software applications such as Electronic Document Management System (EDMS), Quality Management Systems (eQMS), Complaint Management Systems, etc.
  
  

Why work for us

Join an interwoven collection of talented, motivated, and like-minded individuals that share core values and a common goal of boosting science and improving life. We’re proud of our stellar 100% remote team, scattered around the globe from Jodhpur to Antwerp and from Barcelona to Miami. After all, we know location shouldn’t limit potential! We’re all in different time zones, but we make sure to stay connected through work chats and video calls, and team-building outings that are great fun.

We're a friendly bunch that don't take ourselves too seriously yet still get things done, and you can ask anything to anyone. What’s more, even though we’re office-free, we’ll set you up with all the hard- and software you need (hello, new laptop!) so that together we can blast off to great new heights. Since everyone benefits from a great work/life balance, we listen carefully to what you want and need from us to shine, and we'll do our best to provide it. If you're driven, bright, and ready to be part of our company's rapid growth, we can't wait to welcome you aboard!

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