Назад
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9 дней назад

CQV Supervisor

88 536 - 138 338CAD
Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Canada
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
CQV Supervisor (GMP commissioning, qualification and validation): Leading Facilities, Utilities and Equipment CQV for regulated manufacturing systems with an accent on lifecycle management, thermal validation, inspection readiness, and cross-functional technical leadership. Focus on developing qualification strategies, approving IQ/OQ and validation documentation, resolving discrepancies, and maintaining systems in a validated state.

Location: Windsor, Nova Scotia, Canada; onsite work across office, laboratory, manufacturing, warehouse, and utility environments

Salary: CAD 88,536–138,338 per year, plus eligibility for bonus, stock, and benefits

Company

hirify.global supports regulated biotechnology and pharmaceutical manufacturing operations through engineering, quality, and technical services.

What you will do

  • Lead the Facilities, Utilities, and Equipment Commissioning, Qualification, and Validation (CQV) program.
  • Plan and coordinate commissioning, qualification, requalification, and lifecycle activities for GMP facilities, utilities, manufacturing equipment, laboratory equipment, and related systems.
  • Develop, review, and approve validation plans, IQ/OQ protocols, thermal mapping protocols, technical assessments, deviations, and summary reports.
  • Provide technical oversight for thermal validation of autoclaves, controlled-temperature units, refrigerators, freezers, incubators, environmental chambers, and similar systems.
  • Support investigations, CAPAs, change controls, risk assessments, remediation activities, audits, and regulatory inspections.
  • Supervise, mentor, and develop Engineering Technicians while coordinating with Engineering, Manufacturing, Maintenance, Automation, Quality, Technical Operations, and external vendors.

Requirements

  • Bachelor’s degree in Engineering, Biotechnology, Biological Sciences, Food Science, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related technical discipline; equivalent education and relevant GMP experience may be considered.
  • At least three years of relevant experience in pharmaceutical manufacturing, biotechnology, or another regulated GMP environment.
  • Experience in commissioning and qualification, validation, Technical Operations, manufacturing support, engineering, quality systems, or related technical functions.
  • Experience with GMP documentation and quality systems, including investigations, deviations, CAPAs, change controls, or risk assessments.
  • Strong understanding of GMP requirements, regulatory expectations, CQV lifecycle principles, technical writing, analysis, troubleshooting, planning, and cross-functional communication.
  • Proficiency with Microsoft Office Suite; occasional after-hours support and travel may be required.

Nice to have

  • Experience with equipment qualification, IQ/OQ, thermal validation, or CQV lifecycle activities.
  • Previous supervisory, team leadership, or project leadership experience.
  • Experience with electronic validation systems such as Kneat.
  • Familiarity with FDA, Health Canada, ISPE, ASTM, GAMP, or other applicable industry guidance.

Culture & Benefits

  • Full-time day schedule with no planned end date.
  • Opportunity to lead continuous improvement of CQV processes and execution practices.
  • Bonus, stock, and benefits eligibility.
  • Work involves collaboration across Engineering, Manufacturing, Maintenance, Automation, Quality, Technical Operations, and external vendors.

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