TERM - Associate Specialist II, Validation

Winnipeg, MB, CA, R3T 5Y3

Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.

Job Summary - THIS IS A TERM POSITION WITH AN ANTICIPATED END DATE TO BE DETERMINED

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.

Responsibilities

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Responsible for process related activities including the development of validation strategies, the estimation of validation timelines and resource requirements, the generation and approval of the project validation plans, the 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 the 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 the necessary regulations. Participate in audit interviews and support audits, performed by regulatory agencies. Function as system administrator for defined computerized systems