C&Q Engineer - Toronto, Canada - Brevitas

    Brevitas
    Brevitas Toronto, Canada

    2 weeks ago

    Default job background
    Full time
    Description
    Resolute Workforce Solutions (subsidiary of Brevitas Consulting Inc.) is dedicated to helping organizations achieve tangible results and lasting improvements via successful project delivery, continuous process improvement, and effective management of change. We serve businesses in a wide range of industries including Pharmaceuticals, Biotechnology, and Food & Beverage industries.
    We are looking for a highly motivated and energetic individual to join our team as a C&Q Engineer in North York, ON .
    This is an on-site position.
    Responsibilities:
  • Support all activities associated with the Commissioning & Qualification of Equipment and Processes in Pharmaceutical Manufacturing Facility.
  • Review Environmental Monitoring (EM) associated documentation (Strategies, SOPs, Protocols, Raw data review, Reports).
  • Review and approve Analytical Instrument Qualification documents associated with various analytical instruments (HPLC, UV/VIS Spectrophotometer).
  • Apply and interpret cGMP, regulatory requirements, standards, directives, and guidelines from regulatory agencies.
  • Review and approve specifications, qualification protocols, data packs, and qualification summary reports associated with Facility, Utility, and Equipment (FUE) and Process.
    • Qualifications:
  • Bachelor's degree in the field of Engineering or Science.
  • 5+ years of experience in a GMP-regulated environment.
  • Strong technical background and knowledge in both FDA/EU quality compliance requirements and validation requirements.
  • Experience with Document Management Systems (such as QualiPso) and trained in Change Management, LIMS – Nugenesis, and Validation system – Kneat.
  • Expertise in supervising third-party manufacturers for GMP compliance as with regards to documentation would be an asset.
    • Benefits: Upon successful completion of probation, you will also be enrolled in our benefit programs:
  • Life Insurance
  • Accidental Death
  • Long Term Disability
  • Dental and Healthcare
    • To Apply :
  • Click the "I'm interested" button below, or
  • E-mail your resume in MSWord or pdf format to with the following details in the e-mail's Subject Line: C&Q Engineer : FIRST NAME, LAST NAME .
    • We thank all applicants in advance; however, we will only contact the candidates whose qualifications match closely to the job requirements.
    We welcome and encourage applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection our for more information.