Validation Engineering Specialist I
Skills
About the role
This is an entry-level, onsite validation engineering role at Thermo Fisher Scientific in Whitby, Ontario, focused on process and packaging validation. It suits a recent graduate in engineering or a science field who wants to start a career in pharmaceutical manufacturing quality and compliance. No prior experience is required.
What you’ll do
- Support planning, execution and documentation of validation activities across Process and Packaging Validation
- Support Cleaning Validation, Continued Process Verification and Computer System Validation as needed
- Work with cross-functional teams to maintain quality standards
- Support continuous improvement initiatives
What they’re looking for
- Bachelor's degree required, no prior experience required
- Preferred fields of study: engineering, chemistry, biotechnology, biology or related scientific field
- Strong knowledge of validation principles including IQ/OQ/PQ protocols and FDA/EMA regulatory requirements
- Proficiency in statistical analysis and tools like Minitab
- Strong documentation skills and attention to detail
- Expertise in Microsoft Office and validation management systems
- Knowledge of data integrity requirements and 21 CFR Part 11 compliance
- Ability to work independently and in cross-functional teams
Nice to have
- Experience with process/packaging validation, GMP manufacturing or quality
- Experience with risk assessment methodologies
What’s on offer
- 7.5 hour shift schedule
- Estimated annual pay range of $46,600-$69,850 CAD
Questions about this role
Is this role remote?
No, it's an onsite role at the Whitby, ON facility.
How much does it pay?
The estimated annual pay range is $46,600 to $69,850 CAD.
Do I need prior experience?
No, the posting states no prior experience is required, though a bachelor's degree is required.
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