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Associate Specialist, Validation

Location: 

Winnipeg, MB, CA, R3T 5Y3

 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

 

ASSOCIATE SPECIALIST, VALIDATION (CANADA)

3 Positions Available – Term and Permanent Positions

 

Emergent BioSolutions is currently seeking an Associate Specialist for our Validation Department. The select candidate will possess a BS in Engineering/Chemistry/Microbiology or in another related field, cGxP validation experience and experience with investigations and root cause analysis. Must have excellent technical writing and verbal communication skills and the demonstrated ability to manage complex validation projects in a fast paced environment. The ideal candidate will have a strong knowledge of engineering and related practices including governmental regulations, have experience with systems such as Controlled Temperature units, Critical Utilities, Facilities and equipment, preferably used in a GMP environment. In addition, this individual will possess a strong work ethic and a commitment to excellence and innovation.

 

THE COMPANY

 

Emergent BioSolutions is dedicated to one simple mission—to protect and enhance life.

As a global specialty pharmaceutical company, Emergent offers specialized products to healthcare providers and governments to address medical needs and emerging health threats.

 

We value the diversity that each employee brings, and while we look for people who share our Core Values, we thrive on difference as well. With hundreds of talented employees working around the globe, Emergent is a growing organization with a wide variety of scientific, technical and professional career opportunities worldwide.

 

THE OPPORTUNITY

 

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 I authors, reviews and executes qualification and validation documents including process equipment, controlled environments, critical utilities, critical facilities and decontamination / sterilization of equipment.

 

DUTIES & RESPONSIBILITIES

 

  • 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.
  • 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.

 

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.
  • 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
  • Adaptable and flexible.

 

ADDITIONAL REQUIREMENTS:

  • Citizenship/Permanent Resident or Valid Work Permit.
  • Successful Completion of a Criminal Record Check.
  • Medical assessment required upon hire.

 

Interested? Please visit www.emergentbiosolutions.com under the career section to apply today!

 

 

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 Privacy Policy.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.