Validation & Engineering Group, Inc. logoValidation & Engineering Group, Inc. logo

Computer System Validation Specialist

On-site Full-time

Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.


Experience Level

Mid to Senior

Qualifications

The ideal candidate should have:A strong understanding of computer system validation processes and regulatory requirements. Experience with Maximo CMMS and data management. Excellent analytical and problem-solving skills. Strong communication skills and the ability to work collaboratively in a team-oriented environment. A degree in a related field is preferred.

About the job

We are seeking a skilled Computer System Validation Specialist to join our team. The successful candidate will be responsible for developing User Requirement Specifications (URS), managing Document Change Approvals (DCA), and conducting impact assessments for engineering and computer system validation. Key responsibilities include:

  • Managing DCA processes, including document numbering, uploads, and routing for approval.
  • Performing Systems Impact Assessments, distinguishing between engineering and CSV impacts.
  • Entering data and managing spare parts within Maximo CMMS, including instruments for temperature/humidity, calibration forms, and job plans for electrical and mechanical equipment.
  • Developing commissioning protocols, performing testing, and preparing reports for approval.
  • Creating Risk Assessments and Validation Plans, ensuring all documents undergo a structured review process.
  • Managing the installation and data collection from temperature and humidity data loggers.
  • Contributing to the development and execution of Turn Over Packages (TOP) and Standard Operating Procedures (SOPs).

About Validation & Engineering Group, Inc.

Validation & Engineering Group, Inc. is a premier service provider offering innovative solutions to the Pharmaceutical, Biotechnology, Chemical, and Medical Device industries. Our expertise spans Laboratory, Compliance, Computer, Engineering, Project Management, and Validation services throughout Puerto Rico and the USA.

Similar jobs

Browse all companies, explore by city & role, or SEO search pages.

Tailoring 0 resumes

We'll move completed jobs to Ready to Apply automatically.