Validation Engineering Specialist I

Work Schedule 7 1/2 hr shift Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION: Join us as a Validation Engineer at Thermo Fisher Scientific, where you'll contribute to ensuring product quality and regulatory compliance. You'll be responsible for primarily supporting the planning, execution, and documentation of validation activities across Process and Packaging Validation. The role may also require support of other validation areas, including Cleaning Validation, Continued Process Verification (CPV), and Computer System Validation (CSV), based on operational needs. Working with cross-functional teams, you'll help maintain our high standards of quality while supporting continuous improvement initiatives. This role offers excellent opportunities for professional growth within an established leader in serving science. Education: • Bachelor's Degree required, no prior experience required • Preferred Fields of Study: Engineering, Chemistry, Biotechnology, Biology, or related scientific field REQUIREMENTS: • Strong knowledge of validation principles including IQ/OQ/PQ protocols and FDA/EMA regulatory requirements • Proficient in statistical analysis and use of tools like Minitab • Experience with Process/ Packaging validation, GMP manufacturing or Quality preferred • Strong documentation skills and attention to detail • Expertise in Microsoft Office suite and validation management systems • Excellent written and verbal communication skills in English • Ability to work independently and as part of cross-functional teams • Strong problem-solving abilities and analytical mindset • Experience with risk assessment methodologies • Knowledge of data integrity requirements and 21 CFR Part 11 compliance • Ability to manage multiple priorities effectively • Flexible schedule may be necessary for time-sensitive validation activities Compensation The estimated annualized pay range for this position in Ontario is $46,600.00–$69,850.00.

The Validation Engineering Specialist will support the planning, execution, and documentation of validation activities, including process, packaging, and cleaning validation. They will work with cross-functional teams to ensure regulatory compliance and support continuous improvement initiatives.

Candidates must hold a Bachelor's degree in Engineering, Chemistry, Biotechnology, Biology, or a related scientific field. Strong knowledge of validation principles, regulatory requirements, and statistical analysis tools is required.

• Résolution de problèmesSouhaitée
• DocumentationSouhaitée
• Microsoft OfficeSouhaitée
• Communication SkillsSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Validation principles
• IQ/OQ/PQ protocols
• FDA/EMA regulatory requirements
• Statistical analysis
• Minitab
• Process validation
• Packaging validation
• GMP manufacturing
• Documentation
• Microsoft Office
• Validation management systems
• Communication skills
• Problem-solving
• Risk assessment
• Data integrity
• 21 CFR Part 11
• Statistical Analysis
• Continued Process Verification
• Qualification Protocols (IQ/OQ/PQ)
• Cleaning Validation
• Planning
• Title 21 Of The Code Of Federal Regulations
• Biotechnology
• Biology
• Science Education
• Good Manufacturing Practices
• Chemical Engineering
• Regulatory Compliance
• Computer System Validation
• Continuous Improvement Process
• Data Integrity
• English Language
• Packaging And Labeling
• Leadership
• Problem Solving
• Personal Protective Equipment
• Safety Standards
• Risk Analysis
• Verbal Communication Skills
• Product Quality (QA/QC)
• Detail Oriented

• Engineering
• Science & Research
• Manufacturing
• Healthcare
• Validation Engineer
• Validation Specialist
• Process Control Technicians Not Elsewhere Classified
• Validation Engineers
• Industrial Engineers

Formation minimale

Baccalauréat

Expérience minimale

0+ ans

Langue de l’offre

anglais

Heures de travail

38 heures par semaine