Computer System Validation (CSV) Associate
Computer System Validation (CSV) Associate
NNIT is one of the world’s leading consultancies in IT development, implementation and operations serving the Life Science industry for over 20 years. We have applied the latest advances in technology to make software development, business processes and communication significantly more effective for our clients, some of the leading pharmaceutical, biotech, and medical device companies in the industry.
NNIT has grown by more than 1,000 people globally over the last four years globally, is in the process of rapidly expanding their US Operations, and has a number of exciting opportunities. NNIT’s unique culture and approach to business is quickly making NNIT an employer of choice in the US.
We believe "happy employees create happy customers" and has created one of the most unique employee cultures in the industry that offers world-class benefits and numerous opportunities for career growth and advancement. Find out what about the exciting new opportunities NNIT has to offer today!
Computer Systems Validation (CSV) Consultant
We are currently seeking an experienced and dedicated Computer Systems Validation (CSV) Consultant to work out of our Princeton offices supporting one of our top clients.
This person will be responsible for:
Creating computer system validation (CSV) deliverables (Validation Plans, Requirements, Design Specs, Test Scripts (IQ / OQ / PQ), Summary Reports, Trace Matrices, SOPs)
Execute validation test plans and document results
Perform validation activities in some of the following systems: LIMS (e.g. Watson, SampleManager), , Validation Lifecycle Software (e.g. ValGenesis), QMS (e.g. TrackWise), Learning Management System (e.g. SumTotal)
Perform work in Quality Management System (QMS) records (e.g. Deviations, CAPAs, Change Management)
5 – 7 years’ experience validating GxP systems within the pharmaceutical, biotech, or medical device fields
Able to create computer system validation (CSV) deliverables (Validation Plans, Requirements, Design Specs, Test Scripts (IQ / OQ / PQ), Summary Reports, Trace Matrices, SOPs)
Familiar with one or more of the following types of systems: LIMS (e.g. Watson, SampleManager), , Validation Lifecycle Software (e.g. ValGenesis), QMS (e.g. TrackWise), Learning Management System (e.g. SumTotal)
Working experience with Quality Management System (QMS) records (e.g. Deviations, CAPAs, Change Management)
Able to understand current work processes and suggest process improvements
Able to work both as part of a team and independently
Able to travel, including international travel
Excellent communication skills (verbal, written)
Must be willing to work out of Princeton, NJ office and travel to client sites within the NY/NJ/CT area as needed.
No Visa Sponsorship is available at this time. No accepting Corp-to-Corp Applications at this time.
Application deadline 28/02/2017
IT ADVISORY, DEVELOPMENT & OUTSOURCING
NNIT is a fast-growing IT company with ambitious goals. We supply IT services to large enterprises, the public sector and the life science industry - customers that demand high levels of quality and security.
At NNIT, you can make your mark on some of the most challenging projects in the IT industry, on our journey forward as a company, and on your own career.
We take on the responsibility for our clients' IT as if it were our own, and we live our values every day, so you should be able to see yourself in them. We are: Conscience driven. Value adding. Open and honest.
We regard diversity as a strength and support equal opportunities for all. We encourage applications from people of all ages, genders, religions and ethnic backgrounds.
IT advisory, development and operations with a strong focus on life sciences, finance, the public sector and large enterprises with equally high demands on quality and security.
As an international candidate applying for a job, what should one always remember when writing an application?
We do not have any specific requirements to international candidates applying for a job at NNIT. We expect all our candidates to send us a detailed CV and an application that shows your motivation, ambitions and why you are the right candidate for the job.