25 days old

Specialist I, QA Validation

Emergent BioSolutions Inc.
Winnipeg, MB R3B

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.

 

SPECIALIST I, QA VALIDATION

13 Month Term

 

Emergent BioSolutions is currently seeking a Specialist I, for our QA Validation Department at our Winnipeg location. The successful candidate will have a BS Engineering/Chemistry/Microbiology or a related field, have a minim of 5-7 years of related experience in the area of validation and exceptional  knowledge of validation principles and concepts 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 missionto 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 and, where required leading projects to ensure that equipment, facilities, utilities, processes and computer systems utilized in the manufacture of product are validated for intended use.

The role will also be responsible for providing leadership and technical guidance aimed at implementing best practices and improving the overall performance of the validation team and quality processes.

 

 

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 processes.
  • Working with the cross functional teams in the development and execution of validation activities associated with new equipment, processes or system upgrades.
  • Participating in project activities including design of systems and equipment to ensure that they comply with applicable regulations & International Standards.
  • Providing technical input into all phases of the validation lifecycle, i.e. from design through to the commissioning and qualification execution phase and through to validation maintenance.
  • Review and approval of documents prepared by the validation team, other departments and contractor organizations as required.
  • Resolving and assisting in the closure of 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.
  • Minimum 5-7 years related industrial experience in the area of validation.
  • Expert knowledge of validation principles and concepts.
  • Demonstrated ability to manage complex validation projects in a fast paced environment is required.

 

Skills

  • Possesses Strong knowledge of CSV/GAMP, 21 CFR Part 11, Annex 11, Project Life Cycle and quality systems, cGMP, GDP and FDA/EMEA guidelines and proven ability to apply guidelines to all aspects of validation activities.
  • Possesses strong knowledge of engineering and related practices, including governmental regulations ISPE, EU, 21CFR 210, 211, Part 11. 
  • Experience with Aseptic/Sterile Manufacturing and /or Qualification experience within the pharmaceutical or biopharmaceutical industries is preferred.
  • 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.
  • Excellent communication and organizational skills.
  • Adaptable and flexible.

 

ADDITIONAL REQUIREMENTS:

 

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

 

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 actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe 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.

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Posted: 2020-12-31 Expires: 2021-02-07

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Specialist I, QA Validation

Emergent BioSolutions Inc.
Winnipeg, MB R3B

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