Validation Engineer

North York - Ontario - Canada - Life Sciences & Health Care - Pharmaceutical - Project Management & Services - Academic Bachelor

We’re hiring Validation Engineer for our client who is a multinational pharmaceutical company. This iis a contract opportunity of 1 year (12 months).

Feel free to contact

Maria Camanag, Account manager

Apply now

About this role

Responsibilities

  • Coordinate and execute fermentation and microfiltration process development and optimization for Component Pertussis, Diphtheria, and Tetanus
  • Test and develop protocols for use of Process Analytical Technologies (PAT) for use in B100
  • Perform single-use technology assessment studies
  • Deliver a strong and comprehensive characterization and validation package in collaboration with the Mtech B100 team and other key players (ARD, AP&T, BRD, QC, etc)
  • Support the qualification of upstream process equipment to ensure full compliance to process specifications/ requirements, industry standards and quality aspects
  • Review process flow diagrams, mass balances and process descriptions and process assessments/impacts including critical parameters
  • Participate in Functional Component Criticality Assessment for process equipment to ensure alignment with process requirements and specifications
  • Assess new technology implementations , including closed system, PAT, and single-use technology
  • Support C&Q activities: including (but not limited to) SAT, IQ, and OQ of the applicable process equipment/systems in conjunction GEM, Operations and Quality/validation
  • Oversee design and execution of scale-down of manufacturing processes to support validation and characterization.
  • Demonstrate adequacy of the solutions selected with the process needs.
  • Collect and properly interpret data generated from execution of studies.
  • Perform process development and validation with industrial equipment, that includes isolators, fermentors, centrifuges, and microfiltration systems
  • Execute process validation studies, developing detailed validation and study protocols/reports related to process, cleaning, decontamination, and related supportive studies.
  • Ensure documentation is compliant with Sanofi Pasteur policies and regulatory expectations. Take accountability for technical accuracy.
  • Contribute to trouble-shooting and root cause analysis
  • Assist in sample and material management during engineering, technical and consistency batches
  • Provide training on operation/use of process equipment (within areas of equipment specialization)
  • Ensure process knowledge transfer throughout all phases of project execution up to and including consistency lots and regulatory preparation
  • Provide technical advice and guidance to the upstream team

About you

Requirements

  • B.Sc. or M.Sc. with an Engineering background preferred, in Biochemistry or related field
  • Minimum 3 years direct experience in biotech R&D, manufacturing, and quality environments/ organizations. This includes hands-on experience with fermentors, centrifuges, filtration systems, and single-use technology
  • Demonstrated technical competencies in biopharma or life science industry
  • Sound knowledge in fermentation and harvest techniques is a must.
  • Experience in process industrialization is an asset but not required
  • Demonstrated understanding of current Good Manufacturing Practices
  • Equipment and process validation experience
  • Excellent verbal and written communication skills
  • Strong technical writing is essential

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

  • Publication: PUB228718
  • Location: North York
  • Market: Life Sciences & Health Care
  • Hours per week: 35
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of expertise: Project Management & Services
  • Closing date: Sunday, October 13, 2019
Apply now

Feel free to contact

MC

Maria Camanag

Account manager Brunel Canada Toronto

+1 416 244 2402

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