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Associate Specialist II, Validation Expert

2 months ago

Winnipeg, Manitoba, Canada Emergent BioSolutions Inc. Full time
Job Summary

This role is responsible for supporting the validation effort to ensure that equipment, facilities, utilities, and computer systems utilized in the manufacture of product are validated for intended use.

The Associate Specialist II, Validation authors, reviews, coordinates, and executes qualification and validation documents, including process equipment, controlled environments, critical utilities, critical facilities, and decontamination/sterilization of equipment.

Key Responsibilities
  • Responsible for process-related activities, including the development of validation strategies, estimation of validation timelines and resource requirements, generation and approval of project validation plans, development of robust and efficient validation test protocols and reports for new and existing facilities, utilities, and equipment.
  • Responsible for the coordination, communication, and completion of assigned validation tasks.
  • Operate instrumentation to perform various environmental monitoring studies (temperature, relative humidity, etc.).
  • Assist with reviewing User Requirements Specifications, Factory Acceptance Tests, and Site Acceptance Tests for facilities, equipment, and utilities.
  • Author documents such as procedures, summary reports, and status reports related to data integrity as required.
  • Function as system administrator for defined computerized systems.
  • Working with cross-functional teams in the development and execution of validation activities associated with new equipment, system, and facility upgrades.
  • Review and approval of documents prepared by the validation team, other departments, and contractor organizations as required.
  • Resolving and assisting in the closure of deficiencies/deviations initiated during validation activities or as related to critical process parameters.
  • Assisting in the implementation of any existing validation program to ensure continued compliance to necessary regulations.
  • Participate in audit interviews and support audits performed by regulatory agencies.
  • Function as system administrator for defined computerized systems.
Requirements
  • BS Engineering/Chemistry/Microbiology or related field.
  • Desirable cGxP validation experience in the areas of data integrity, installation qualification, operational qualification, and performance qualification.
  • Experience with investigations and root cause analysis principles.
  • Excellent technical writing and verbal communication skills.
  • Demonstrated ability to manage complex validation projects in a fast-paced environment is required.
Skills
  • Possesses strong knowledge of engineering and related practices, including governmental regulations – ISPE, EU, 21CFR 210, 211, Part 11.
  • Experience with systems such as Controlled Temperature units, Critical Utilities, Facilities, and equipment, preferably used in a GMP environment.
  • Demonstrates success in technical proficiency, creativity, and collaboration with others and independent thought.
  • Makes decisions exercising judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Excellent attention to detail, with an ability to work to very tight schedules.
  • Possess the ability to adapt to a dynamic project schedule with varying levels of complexity.
  • Advanced skills and fluency in Microsoft Word, Outlook, and Excel.
  • Experience with laboratory instrumentation/equipment and control systems used in GMP and/or GLP environment.
  • Possess strong communication and project management skills.
  • Adaptable and flexible.
  • Pre-employment medical assessment is required.