Entry Level Computer Systems Validation Engineer
PSC Biotech Corporation
San Juan
hace 2 días

PSC Biotech is a leading process consulting and contract engineering company. For over 19 years we have been engaged in providing laboratory support, project, process, engineering and validation support to top-tier pharmaceutical and biotech companies.

We are looking for an Entry-Level Computer System Validation Engineer. This role would work alongside an amazingly talented PSC Team, and works under the leadership of one of the best in the industry!

Successful candidates will have excellent verbal and written communication skills, an understanding of the IT realm, and a thirst to learn!

Responsibilities :

  • Provide CSV authoring, review and approval of validation documents developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards.
  • Initiate / update GxP and Risk Assessments on system.
  • Author, Review and or approve scheduled periodic reviews.
  • Author, Initiate, and / or review and approve IT SOPs related to compliance
  • Collaborate with project stakeholders and the information systems team to define needs and achievable solutions and / or justifications to system requirements
  • Draft and execute computer system validation documentation
  • o Validation Project Plan

    o Requirement Specification (URS, DS, FS)

    o IQ and OQ Test Scripts

    o IQ / OQ / PQ Protocols, as necessary

    o Traceability Matrix (TMX)

    o System Release Memo

    o Validation Summary Report

  • Translate system requirement specifications into executable validation protocols
  • Provide support to executors of the protocols when needed
  • Write reports summarizing system validation
  • Requirements

  • Bachelor’s Degree in Chemical Engineering, Biomedical Engineering, Computer Science or IT / IS from a 4 year University
  • Must have strong written and verbal communication skills
  • Previous experience in IT Industry is preferred
  • Previous experience in GxP Industries are preferred
  • Must be adaptable, customer service oriented, have a positive attitude
  • This role requires additional hours worked. You must have a flexible schedule
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