R.A. Wylan & Co. Inc.,
Career Center

Validation Manager, (Computer Systems)

Location: Any US City
Job Type: Direct Hire
Salary: $100,000.00 - $130,000.00
Degree: Bachelor;
Date: 9/14/2017
Job ID: 02522489
Job Description
Title: Computer Systems Validation, Mgr
CSV Specialist prepare, execute, and summarize validation protocols and other validation related documents (risk assessments, validation plans, traceability matrix, periodic reviews, URS, FRS, IQ/OQ/PQ, etc.) to support new or existing computerized system, including spreadsheets, used for or in support of GMP activities.
  • Provides compliance leadership, direction, and oversight in the area of Computer System Validation.
  • Develops and maintains computerized system life cycle documentation: user requirement specifications (URS), functional requirement specifications (FRS), design specifications, risk-analysis, traceability matrices, standard operating procedures, installation qualification protocols, operation qualification protocols, performance qualification protocols, validation master plans, and summary reports.
  • Maintains awareness of current regulatory trends and their impact on the validation status of computerized systems.  Provide interpretation and recommendations on compliance with FDA / EU Regulations regarding CSV related issues
  • Conducts 21 CFR Part 11 assessments on new and existing computerized systems. 
  • Bachelor’s degree, preferably in a technical/science/mathematical field.
  • Knowledge of servers, networks, enterprise systems, servers and standalone workstation applications in the Microsoft environment.
  • Familiarity with GAMP5 risk based approach along with V model and other approaches to System.
  • Validation experience in a biotech/pharmaceutical environment, specializing in Computer System Validation.