Computer System Validation (CSV) Associate

NNIT A/S

Fuldtidsjob
Udlandet (øvrige)

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 clients San Francisco area offices supporting one of our top pharmaceutical clients.

Description:

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)

Requirements
 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 28/06/2019

About NNIT

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.

Contact


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Fuldtidsjob
Udlandet (øvrige)
IT
Kemi, Biotek & Materialer
Teknik & Teknologi
IT - Software



NNIT A/S - hurtigt overblik


NNIT A/S
NNIT A/S
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.

Placering
Østmarken 3A
2860 Søborg
Logo: NNIT A/S
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