Validation Engineering Specialist II - Equipment Engineering
$56.4k - $84.6k per yearThermo Fisher Scientific
Validation Engineering Specialist II at Thermo Fisher Scientific provides specialized expertise in equipment and process validation within a GMP-regulated pharmaceutical manufacturing environment. The role involves developing validation protocols, coordinating manufacturing activities, analyzing data, and ensuring compliance with company standards and regulatory requirements.
Responsibilities
- Prepare validation protocols and final reports for equipment, processes, packaging and cleaning
- Monitor manufacturing execution and deliver training on validation methodologies
- Conduct data collection, statistical analysis and coordinate swab sampling activities
- Develop risk assessments and continued process verification documentation
- Engage with clients, project managers and stakeholders to advance validation initiatives
Requirements
- Post-secondary diploma in Chemistry, Engineering, Science or related field; BSc preferred
- 2–3 years validation, process engineering, or quality experience in pharmaceutical/biotech
- Strong written and verbal communication with meticulous attention to detail
- Statistical analysis and data analysis knowledge; Mini-Tab experience an asset
- Microsoft Office proficiency and English language fluency
- Ability to multitask under tight deadlines in fast-paced environments
Compensation: $56,400–$84,600 CAD annualized
Vacancy posted 11 days ago
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