Xyntek is seeking entrepreneurial, 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 Software/Product Development Lifecycle (SDLC) activities on software application development and integration projects.
The ideal candidate will provide technical consulting and project support on various software development and implementation projects, including design, programming, configuration, and integration.
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 Assessments
- 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
- Minimum 3 - 5 years work experience in the Life Sciences (Pharmaceutical, Medical Devices) and Healthcare industries
- Minimum 3 - 5 years in computer systems validation / QA within FDA (GxP) regulated environments.
- Experience with validating and qualifying various IT systems and equipment used in lab, clinical, and manufacturing & packaging, sales & reporting environments.
- Experience of implementing technologies following SDLC methodologies
- Experience using automated testing tools (i.e.; HP Quality Center)
- 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 and related IT degrees
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:
- Medical Device
- Healthcare IT (Hospitals)
, employees are our most valuable resources, and an integral part of our success. We work hard and play to win. Xyntek
offers excellent benefits, competitive salaries, and a high energy work environment.
|Company Provided Benefits |
- Paid Vacations
- Company Matched 401(k) & Profit Sharing with 100% vested upon enrollment in the plan
- 100% Company Paid Health Insurance
- Annual Performance Based Raises & Bonuses
- Company Sponsored Social Gatherings & Events
- Fast Track Technical & Management Career Growth
Positions available for the following locations:
USA-PA, NJ, CA, MD, MA, NC, IN, IL,
Beerse-Belgium, and Puerto Rico