Validation Engineering Specialist II – Equipment Engineering
Skills
About the role
This is an onsite validation engineering role at Thermo Fisher Scientific in Mississauga, Ontario, within Equipment Engineering. It suits someone with a couple of years of validation or process engineering experience in pharma or biotech who can prepare protocols and reports for process, packaging and cleaning validation. The role involves interacting directly with clients and project managers to drive validation activities.
What you’ll do
- Prepare validation protocols and reports for process, packaging or cleaning validation
- Monitor and coordinate manufacturing execution and provide training on validation protocols
- Perform data collection, statistical analysis and prepare summary reports
- Monitor and coordinate swab sampling activities for cleaning validation
- Prepare risk assessments, protocols and reports for Continued Process Verification
- Prepare protocols and reports for bulk hold and shipping studies
- Interact with clients, project managers and stakeholders to drive validation activities
What they’re looking for
- Minimum post-secondary diploma in chemistry, engineering, science or related field
- 2-3 years of experience in validation, process engineering or quality within pharma/biotech
- Strong written and oral communication skills
- Detail-oriented with a high degree of accuracy
- Strong judgment, decision-making and troubleshooting skills
- Computer proficiency with Microsoft Office
Nice to have
- BSc in chemistry or engineering
- Previous experience with statistical analysis
- Familiarity with Minitab and data analysis
What’s on offer
- Standard Monday-Friday schedule
- Estimated annual pay range of $56,400-$84,600 CAD
Questions about this role
Is this role remote?
No, it's an onsite role at the Mississauga, ON facility.
How much does it pay?
The estimated annual pay range is $56,400 to $84,600 CAD.
How many years of experience do I need?
2 to 3 years of experience in validation, process engineering or quality.
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