Specialist I, Qa Validation - Limited Term

Emergent Biosolutions Inc

Winnipeg, MB, CA
On-site
Validation strategies development
Validation test protocols and reports
Cgmp, gdp, and fda/emea guidelines
This 18-month term role supports validation efforts for equipment, facilities, utilities, processes, and computer systems used in product manufacturing

Job Summary

  • This 18-month term role supports validation efforts for equipment, facilities, utilities, processes, and computer systems used in product manufacturing.
  • Responsibilities include developing validation strategies, generating validation plans, and creating robust test protocols and reports for new and existing processes.
  • The company offers diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements, and an extensive benefits package.

Matching Summary

This 18-month term role supports validation efforts for equipment, facilities, utilities, processes, and computer systems used in product manufacturing.

Skills & Requirements

Must-have

  • validation strategies development
  • validation test protocols and reports
  • cGMP, GDP, and FDA/EMEA guidelines
  • engineering and related practices
  • technical proficiency and creativity

Nice-to-have

  • collaborative and independent thought
  • adaptable and flexible approach
  • strong organizational skills
  • working to tight schedules

Key Requirements

  • BS Engineering/Chemistry/Microbiology or related field
  • 5-7 years related industrial validation experience
  • Expert knowledge of validation principles
  • Manage complex validation projects
  • Strong knowledge of CSV/GAMP, 21 CFR Part 11, Annex 11
  • Experience with Aseptic/Sterile Manufacturing preferred
  • Experience with Controlled Temperature units, Critical Utilities, Facilities, and equipment

Work Rights

Not specified

Tailored Resume

Cover Letter