Canada, Greater Toronto Area
Fulltime: 37.5 hrs a week
Experience: 2 years
Closing: April 14, 2025

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Introduction

Hiring a Quality Manager who will provide expertise, quality oversight, and guidance on regulatory requirements and best practices for manufacturing equipment qualification, including computerized systems validation. The candidate will support validation strategies, quality processes, and cross-functional project teams, including Bulk Manufacturing, Manufacturing Technology, Engineering, and ITS. A strong technical background, problem-solving skills, and commitment to GMP are essential.

What are you going to do 

  • Provide quality oversight for manufacturing process equipment, CIP, SIP, Thermal, Utilities, HVAC qualification and computerized system validation activities pertaining to B100 licensure, start-up and lifecycle management.
  • Review/approve validation deliverables (i.e. URS, specification documents, risk assessment, test strategies, protocols, executed raw data packages, reports, validation plans, SOPs, Equipment registration in SAP) in accordance with internal and regulatory policies.
  • Review, assess and approve change controls, deviations and corrective plans, resulting from validation/qualification studies.
  • As required, represent Quality Operations on project team and/or sub-teams and/or project working groups to provide direction on validation issues with respect to compliance.
  • Responsible for maintaining validation awareness by screening and reporting on significant validation trends and changes through literature reviews, meetings, and peer discussions within the industry.

Essential skills and knowledge 

  • Bachelor's Degree in Engineering / Science or related field
  • 4+ years of experience in a GMP controlled environment/pharmaceutical industry
  • Experience with qualification of manufacturing process equipment is required (examples of manufacturing equipment include: Isolators, Fermentors, Microfiltration and Ultrafiltration systems, Centrifuges, Microplate Readers, etc.)
  • Experience reviewing documentation for completeness, reviewing reports and non-conformances/deviations, administrative tasks and leading meetings.
  • Experience with computerized systems validation is required
  • Validation experience from MSAT or quality side, conducting validation studies 3
  • Biologics or vaccines experience would be a plus
  • Experience with qualification of Delta V, Data Historian OSI PI, and Manufacturing Execution System MES is an asset
  • Technical writing, effective oral and written communication skills, and strong compliance mindset.
  • Good understanding of current and evolving regulatory requirements
  • Strong communication, negotiation, and interpersonal skills and teamwork
  • Good interpersonal and influencing skills are important for a candidate's success
  • Ability to anticipate evolutions due to internal and external factors.
  • Conflict resolution and problem-solving.
  • Familiarity with strategic planning, balanced judgment and risk analysis.

What we offer 

What We Offer

Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. 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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Anything Else?

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Are you ready for the next step in your career? Join Brunel’s powerful global network, where passionate, results-driven specialists come together with industry-leading clients. By connecting specialists to pioneering projects, we drive change in many industries, enabling growth and delivering great outcomes. Brunel helps you reach your full potential and empowers you to make an impact within a purpose-driven global company.

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Our Culture and Values

At Brunel, we are proud of our unique corporate culture, which is shaped and nurtured by the collective efforts of our employees. Our work environment is characterised by an authentic, communicative and inclusive approach to teamwork that fosters an atmosphere of collaboration and creativity. Our values are at the center of everything we do – for our clients, our colleagues and ourselves.

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Our ESG Commitment

Since 1975, our mission has always been to connect specialists to exciting career opportunities, to support the development of these careers, and to offer fair and equal employment. This has enabled us to create a truly sustainable and durable business model. Having a passion for people and caring deeply for the environment is not only part of Brunel’s DNA but is also reflected in our culture and values. As a global company, we take our social responsibility very seriously.

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Do you have any questions about this vacancy ? 

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Sarah Beaton

+1 403 539 5009