Title: Senior Validation Specialist & Validation Specialist II
Summary: A biopharmaceutical organization is currently seeking a Senior Validation Specialist and a Validation Specialist II to join their Ohio headquarters. As the project representative for teams, clients, and stakeholders, you will assist in the development, coordination, and execution of qualifications/validation protocols.
The Senior Validation Specialist & Validation Specialist II will be responsible for…
- Supporting capital projects, plans, and improvements to establish new capabilities
- Preparing and executing equipment qualification plans and protocols
- Writing the Final Summary Reports to summarize executed qualifications/validations
- Coordinating validation-related activities regarding equipment and processes in GMP environments
- Collaborating with Program Management, A&E service providers, Engineering, Validation, Maintenance, Manufacturing, Analytical/Process Development, and Quality Assurance
The Senior Validation Specialist & Validation Specialist II should have the following qualifications:
- Bachelor of Science in Chemical, Biochemical, Biomedical Engineering, or Biological Sciences or equivalent combination of education and experience
- Senior Validation Specialist: 5 years' experience in Validation in a highly regulated industry
- Validation Specialist II: 3 years' experience
- Detailed knowledge of 21 CFR Part 210 and 211
- Proficient in Microsoft Office
If you're interested in both/either the Senior Validation Specialist or Validation Specialist II role, then please don't wait to apply!