Computer Systems Validation Specialist

Location: Central, NJ

Type: Full Time

Min. Experience: Experienced

Xyntek is seeking entrepreneurial-minded, dedicated and motivated employees that are interested in joining a fast-paced Systems Engineering & Consulting Team.  The ideal candidates will be involved in all aspects of computer systems validation and qualification activities as part of an overall Software/Product Development Lifecycle (SDLC) approach.


Responsibilities:    

The selected candidate will provide validation and compliance consulting and project support on various technology development and implementation projects, including planning, solution design, testing, and support.

Project activities will include:

  • Developing and managing GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance testing, traceability matrix, system, Validation Reports, SOPs, Change Control Documentation, and Risk assessment reports.
  • Conducting System Compliance Risk Assessment
  • Managing and coordinating all aspects of the computer systems validation activities as they pertain to SDLC, including project planning, developing validation strategies, document development and document reviews
  • Overseeing system change requests and associated documentation
  • Managing documentation logs and document storage
  • Maintaining system SOPs

 

Qualifications:    

  • Minimum 3 years work experience in the Life Sciences (Pharmaceutical, Medical Devices) and Healthcare industries
  • Minimum 3  years in computer systems validation / QA within FDA (GxP) regulated environments.
  • Specific experience with automated testing tools (i.e.; HP Quality Center)
  • Experience with validating and qualifying various IT systems used in clinical environments.
  • Experience in developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC phases
  • Self-motivated and quick learner of business processes and technologies
  • Excellent Technical Writing and Communication skills
  • Minimum of Bachelors in Computer & Electrical Engineering, Computer Science, Chemical Engineering, Industrial Engineering, Engineering Management, MIS or related IT degrees

About Xyntek:

Established in 1986, Xyntek, Inc. is an Information Technology and Automation Systems Engineering Consulting, Design, Development, and Implementation firm.  Our solutions and services are provided to Fortune 100 companies in the Life Sciences industry including:

o Pharmaceutical
o Medical Device
o Healthcare (Hospital IT)

At Xyntek, employees are our most valuable resource, and an integral part of our continued success. Our team works aggressively and passionately to continue to win and grow. Xyntek offers excellent benefits, competitive salaries, and a high energy work environment and growth.   Benefits include:

Health plan insurance plan covers (medical, dental, & vision.  Plan

is 100% paid by the company. )

401K with company match & profit sharing.  Fully vested after one year of full time employment.

Paid vacations & holidays equivalent to one month's salary. 

100% company paid lunches when working out of the office.

100% Company paid expenses for attendance at Professional conferences and events.

100% Company sponsored social gatherings & events.

Annual performance based raises & bonuses.

Engineering Mentorship Programs.

Fast track technical & management career growth.

Xyntek is an Equal Opportunity Employer with a strong commitment to supporting and retaining a diverse and talented workforce.

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