Associate Specialist II, Validation

3 months ago

Winnipeg, 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.

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.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills

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. Ensure alignment and communication of issues and strategies.
• 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.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our .

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