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Scilife Career Opportunities

Validation Engineer

Do you like to meticulously document and test computer systems? Are you a GAMP5 expert looking for a new challenge?

 

What would your job be like at Scilife?

You would be working within the QA/QC team in close collaboration with the Development team to draft and maintain all the CSV-related documentation to keep our Scilife product validated according to regulations such as GAMP5 and 21CFR11.

 

Your responsibilities:

  • You will be responsible for all things related to validation, from keeping documentation up to date to informing and even educating our customers about what validation is all about.
  • Provide desired support related to computer system validation and Quality Assurance tasks
  • Review the accuracy and completeness of software validation deliverables created by other process teams(e.g., Requirements Specification, IQ, OQ, PQ).
  • Work as part of project team to plan, monitor & review all validation & quality deliverables of the project to ensure compliance with SOPs & regulatory requirements (such as 21CFR Part11 & Annex11) to ensure timely closure of the project.
  • Involved in the preparation and checking of validation-related protocols.
  • Ensures business requirements are met in the final solution.
  • Assisting with the development and maintenance of SOPs, Guidelines, and Policies, and supporting forms and templates.
  • Function as an internal quality consultant instilling a cross-departmental quality mindset.
  • Constantly test and help document the company’s processes to maximize efficiency and maintain regulation compliance

 

What you'll need:

  • Well conversant with GAMP5, 21 CFR Part 11 requirements for CSV & GxP practices.
  • More than 3 years of experience in Computer Systems Validation in the Pharma, Biotech or Medical Devices industries.
  • Strong communication and interpersonal skills.
  • Proactive and with a getting-things-done mindset.


Who is Scilife?

At Scilife we build cloud-based technology that helps our customers in the Pharma, Biotech, and Medical Devices industries manage everything quality, process, and product-related. Our customers make life-saving and life-enhancing products that make a difference in the world. Our technology helps them to get their products and services to market fast while complying with regulatory requirements by providing them with a pre-validated SaaS solution.

 

Why would you 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, a 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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