Validation Supervisor

2 weeks ago

Montreal Quebec, Québec, Canada Brunel Full time

Introduction

We are currently recruiting for a Bilingual (Fr/En) Validation Supervisor for our client. As a Validation Supervisor at a leading pharmaceutical company specializing in sterile products, you will play a crucial role in ensuring that all site processes, equipment, and systems adhere to stringent regulatory standards. You will lead a team of validation specialists to manage validation projects, oversee protocol documentation, and collaborate with cross-functional teams to support new product processes and site modifications.

This is a full-time permanent opportunity to work in a hybrid schedule in the Montérégie region.


Responsibilities

Validation Program Oversight & Compliance:

  • Oversee validation activities and projects, ensuring compliance with regulatory standards and internal procedures.
  • Maintain and improve the validation program to meet FDA and Health Canada requirements.
  • Support new product processes and collaborate with regulatory teams to ensure compliance.

Documentation & Reporting:

  • Prepare and review validation protocols and reports for equipment, cleaning, processes, and computer systems.
  • Maintain the validation documentation system and coordinate reviews of existing equipment validations.

Coordination & Execution:

  • Coordinate validation activities with Production, Quality, and Technical Services teams.
  • Lead validation, revalidation, and qualification efforts to support site modifications and upgrades.

Team & Performance Management:

  • Lead and develop a team of 3 validation specialists, including recruitment, training, and performance management.
  • Monitor and report on monthly validation KPIs and metrics.
  • Manage consultants and proactively address performance issues to ensure alignment with business goals.

Training & Internal Support:

  • Promote and explain validation strategies to internal teams and provide training as needed.
  • Participate in regulatory inspections and manage response processes.

Continuous Improvement:

  • Continuously enhance the validation system to meet evolving regulatory requirements.
  • Conduct risk assessments and manage validation-related investigations.

Ad hoc duties


Requirements

  • Bachelor’s degree in science
  • 5-10 years of experience, including at least 2 years in a sterile pharmaceutical setting and 3 years in personnel management
  • Strong presentation, and verbal and written communication skills in both English & French
  • Proficient in Microsoft Office Suite (Word, Excel)
  • Comprehensive understanding of pharmaceutical regulations
  • Track record of meeting business goals
  • Strong project management and problem-solving skills
  • Ability to effectively advocate for regulatory positions
  • Proficient in interpreting and applying standards
  • Excellent organizational abilities deadline management and adaptability to changing priorities


What We Offer

Why apply through Brunel? Finding the next step in your career can be a full-time job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with onboarding. We’ll get you going while you get on with the job.


About Us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

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