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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.

 

SPECIALIST, VALIDATION

 

Emergent BioSolutions is currently seeking a Specialist, Validation at our Winnipeg location. The successful candidate will have completed post-secondary education in a related field and a minimum of 5 years of related industrial experience. The ideal candidate will have excellent technical writing and verbal communication skills and in understanding of computer systems, including validation and data integrity.    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

 

The Specialist, Validation is a key contributor to the validation team at the Winnipeg Site, including leading projects to ensure that equipment, facilities, utilities and computer systems utilized in the manufacture of product are validated for intended use.

The Specialist 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.
  • Accountable for the scheduling and coordination of validation, calibration and maintenance activities required for cGXP instruments, equipment, and systems.
  • Assist with writing, reviewing, and executing User Requirements Specifications, Factory Acceptance Tests and Site Acceptance Tests for instruments, equipment, and systems
  • Facilitate and manage collaborative, cross-functional team meetings to perform data integrity risk assessments of direct impact equipment and systems to identify and mitigate potential risks.
  • Coordinate and create data flow process models and system configuration documents to ensure equipment and systems meet data integrity requirements.
  • Author documents such as procedures, summary reports, and status reports related to data integrity as required.
  • Function as system administrator for defined computerized systems
  • Work with the cross functional teams in the development and execution of validation activities associated with new equipment, system and facility upgrades.
  • Contribute to  project activities including design of systems and equipment to ensure that they comply with applicable regulations & International Standards and data integrity requirements.
  • Provide 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 approve of documents prepared by the validation team, other departments and contractor organizations as required.
  • Resolve and assist in the closure of deficiencies / deviations initiated during validation activities or as related to critical process parameters.
  • Assist in the implementation of any existing validation program to ensure continued compliance to the necessary regulations.
  • Assist in providing responses to audit observations and manage audit related CAPA commitments

 

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: 

 

  • The completion of the Post-Secondary Program in a related field.
  • 5-7 years of related industrial experience in the area of validation.
  • Desirable experience with laboratory instrumentation/equipment and control systems used in GMP and/or GLP environment 
  • Excellent technical writing and verbal communication skills
  • Expert understanding of computer systems, including validation and data integrity requirements is necessary.
  • Experience with investigations into deviations and determination of impact, root cause, and corrective actions

 

ADDITIONAL REQUIREMENTS:

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

 

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.