Posted: 12 March
Offer description
Job Description
The COMPUTER SYSTEMS VALIDATION CONTRACT ENGINEER will validate/qualify computer systems, including process automation systems, IS applications/infrastructure, and enterprise systems.
This role requires a deep understanding of computer systems validation principles and practices.
A key responsibility is to plan, coordinate, and participate in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
Key Responsibilities:
* Prepares/reviews validation documentation related to projects/change controls.
* Participates in the review of current and future CSV procedures and policies.
* Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
* Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
* Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
* Coordinates with other departments or outside contractors/vendors to complete validation tasks.
* Participates in regulatory audits and communicates company's computer validation policies.
* Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps.
* Manages projects and prepares status reports using Microsoft project and other communication tools.
* May supervise, lead, or manage lower-level personnel.
Requirements:
* BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.
* Experience in a GMP environment essential.
* Biologics experience highly desirable.
