Senior Validation Coordinators
تفاصيل الوظيفة
VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their career in the pharmaceutical, biotechnology and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industries. We are currently seeking Two (2) Senior Validation Engineers for our client in London Ontario Canada. This project will be starting soon and is expected to last for approximately 4+ months. Responsibilities:
- Work with Facilities, QA and Operations and lead in the evaluation and risk assessment of project.
- Ensure all introductions and changes are appropriately documented demonstrating proper design, qualification, operation and maintenance.
- Develop Performance Qualification protocols for Process and sterile drug manufacturing.
- Develop and maintain Validation Master plans and applicable project specific validation plans
- Bachelor of Science in Engineering.
- 5+ years of relevant experience.
- Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
- Proficiency with Microsoft Office Suite.
- Familiar with applicable regulatory guidance on validation, qualification, and sterile drug manufacturing.
- In-depth knowledge of validation and qualification requirements for sterile manufacturing in pharmaceutical environment.
- Significant experience in the generation qualification protocols and validation plans.
- Familiar with applicable regulatory guidance on validation, qualification, and sterile drug manufacturing.
- Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
- Must possess excellent written, organizational and communication skills.
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