1 meilleure offre (biotech, columbus) (à pourvoir)

Validation Engineering Specialist I
Thermo Fisher Scientific —Whitby, ON
- De 46 600 $ à 69 850 $ par an
- Temps plein
- Pas d'expérience requise
- Anglais
- Microsoft Office
il y a 2 jours

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Validation Engineering Specialist I

Thermo Fisher Scientific -
Whitby, ON

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Détails du poste

Temps plein
De 46 600 $ à 69 850 $ par an
Il y a 2 jours

Profil recherché

Statistique
Utilisation de l'équipement de protection individuelle (EPI)
Pas d'expérience requise
Anglais
Bonnes pratiques de fabrication (BPF)
Microsoft Office
Minitab
Analyse statistique
Baccalauréat
Amélioration continue
Évaluation des risques
Collaboration interfonctionnelle
Analyse statistique des données
Compétences en communication

Description complète du poste

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.

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Validation Engineering Specialist I

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