CSV Engineer

2 weeks ago

Edmonton, Alberta, Canada PharmEng Technology Full time $80,000 - $120,000 per year


Location: Edmonton, Alberta (onsite role)

Client Industry: Pharmaceutical Manufacturing

PharmEng Technology is seeking an experienced Computer System Validation (CSV) Specialist for a 12-month on-site consulting engagement with our client in Edmonton, Alberta. This role is essential in supporting GMP compliance for critical laboratory systems and software in a sterile manufacturing environment.

Key Responsibilities:

  • Develop and execute validation protocols (URS, FS, IQ, OQ)

  • Qualify laboratory and manufacturing equipment (e.g., sterile filling lines, HVAC, HPLC)

  • Perform CSV activities in compliance with cGMP and regulatory standards

  • Provide hands-on, on-site support and coordination with cross-functional teams

  • Maintain documentation, manage deviations, and support audit readiness

Qualifications:

  • Proven experience in IT Qualification and CSV within GMP-regulated environments

  • Strong documentation and validation protocol development skills

  • Effective communication and stakeholder coordination capabilities

  • Ability to work full-time on-site in Edmonton

About PharmEng Technology:

PharmEng Technology is a full-service consulting firm providing expert compliance and validation services to the pharmaceutical, biotechnology, and medical device industries. We pride ourselves on delivering high-quality solutions through industry expertise and collaborative client partnerships.

If you're a validation professional looking for your next consulting opportunity, we'd like to hear from you.


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