Computer Systems Validation Specialist

Location: Newtown, PA

Type: Full Time

Min. Experience: Mid Level

Location: Newtown, PA

Department: Xyntek Inc.

Type: Full Time

Min. Experience: Mid Level

Company Overview

Established in 1986, Xyntek, Inc. is a professional turnkey Systems Engineering Consulting, Design, Development, and Implementation firm. Our solutions and services are provided to Fortune 100 companies within various manufacturing industries.

Job Summary

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 and Duties

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:

  • Lead the validation activities for a global serialization & ePedigree rollout
  • 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
  • Utilization of a risk based approach to determine the validation requirements
  • Configuration specifications generation detailing the specific configuration of the systems / interfaces
  • Project change control implementation in accordance with requirements, design and system changes
  • Identify risks and clearly communicate them to project stakeholders

Qualifications and Skills

  • 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
  • Experience of validating a serialization or track & trace project is highly advantageous
  • Understanding of packaging processes, warehouse and distribution streams

Benefits:

At Xyntek, 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. Benefits include:

• 100% paid Health insurance covered by the company. No deductions are made from employee's paychecks.
• 100% paid Dental insurance covered by the company. No deductions are made from employee's paychecks.
• 100% paid Eye care plan covered by the company. No deductions are made from employee’s paychecks.
• 100% vesting in our 401K Plan with company match after one year of employment. No vesting schedule to receive and retain the company match.
• Paid Holidays.
• Paid Vacation time.
• 100% company paid lunches when working in the office.
• 100% company paid snacks when working in the office.
• 100% Company paid time, associated fees, all expenses, and travel for attendance at professional events, seminars, conferences, and shows.
• 100% Company paid social gatherings and events.

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