Validation Engineer

North York - Ontario - Canada - Life Sciences & Health Care - Pharmaceutical - Regulatory - Academic Master

We’re hiring a Validation Engineer for our client, a large pharmaceutical company, to join their team. This is a one-year contract.

Feel free to contact

Diana Grodowski, Account manager

Apply now

About this role

Responsibilities

  • Deliver on Process Validation (PV) Plans
  • Collaborate with other B100 teams to support the development and management of various PV documentation, including process and equipment documents such as (but not limited to) URSs, PFDs, FADs. Ensure documentation is compliant with policies and regulatory expectations.
  • Collaborate with current MTech, Production and Quality teams to ensure that all existing validation data, where possible, is included in B100 assessments for establishment of PV supportive data.
  • Manage and maintain B100 validation database for all PV supportive data.
  • Support the development of validation documents, including the authoring of validation protocols and reports in accordance to governing policies.
  • Support the planning and execution of PV studies; collect and properly interpret data generated from execution of PV studies; take accountability for technical accuracy.
  • Deliver on Single Use Technology (SUT) Implementation and Qualification Plans
  • Collaborate with other B100 teams to support the development and management of SUT documentation. Ensure documentation is compliant with policies and regulatory expectations.
  • Collaborate with current R&D, MTech, Production, Quality teams and Vendors to ensure that all existing SUT validation data, where possible, is included in B100 assessments for establishment of SUT supportive data.
  • Manage and maintain B100 validation database for all SUT supportive data.
  • Support the development of SUT implementation and qualification documents, including the authoring of qualification protocols and reports.
  • Support the planning and execution of SUT studies; collect and properly interpret data generated from execution of studies; take accountability for technical accuracy.
  • Participate in project team, working groups and task forces (Local and or global) and ensure responsibility for specific scientific aspects of assigned projects.
  • Assist in SUT inventory, sample and material management during C&Q, engineering, technical and consistency phases.
  • Interact with cross functional teams in Product Development, Production, Quality operations and other internal and external groups (France and USA) to support process and technology transfer, scale-up, process improvement and validation. Ensure that strategies developed during scale-up are implemented when appropriate.

About you

Requirements

  • Minimum 1-2 years direct experience in biotech R&D, manufacturing, and quality environments/ organizations Demonstrated technical competencies in biopharma or life science industry
  • they should aware of technical process requirements for vaccines (ex: vaccine process, upstream and downstream process and each step)
  • Sound knowledge of process validation requirements and single use technology
  • Demonstrated understanding of current Good Manufacturing Practices (GMP)
  • Experience in process industrialization
  • Equipment and process validation experience
  • Excellent verbal and written communication skills
  • Strong technical writing is essential
  • experience in protocols and writing reports and procedures in a GMP environment.
  • M.Sc.; Biotechnology background preferred but a Bachelors' degree is the minimum requirement

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Vacancy number: PUB219589
  • Location: North York
  • Market: Life Sciences & Health Care
  • hours per week: 35
  • Branche: Pharmaceutical
  • Education level: Academic Master
  • Area of Expertise: Regulatory
  • Closing date: Thursday, August 15, 2019
Apply now

Feel free to contact

DG

Diana Grodowski

Account manager Brunel Canada Toronto

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