- The project entails providing validation support for project execution, drafting documentation for FDA compliance related to new processes or packaging equipment, and collaborating with site engineers to detail documents and support execution and sign-off.
- Responsible for drafting various types of documentation necessary for FDA compliance related to new processes or packaging equipment.
- This documentation includes: User Requirement Specifications (URS), Functional Requirements Specifications (FRS), Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validation protocols, and reports.
- Must have validation and document generation experience.
- Familiarity with FDA standards, particularly 21 CFR Part 11.
- Experience in pharmaceutical validation roles is desirable.
- Familiarity with Microsoft Project and M Files is preferred, though training can be provided if necessary.
- Will candidates with experience in IQ, OQ, and PQ writing in a manufacturing or production setting.
- Validation experience
- Document generation and writing exp
- Familiarity with FDA standards and 21 CFR Part 11
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Validation Engineer III - Columbus, United States - Intellectt Inc
Description
Role: Validation Engineer III
Location: Columbus, OH
Duration: 12 Months on W2
- 100% Onsite role.
- Local candidates will be given preference who can come onsite for the second round of interviews.
- Will also consider candidates who are non-local and willing to relocate at their own expense.
Skills Looking For:
Education and Experience:
A bachelor's degree in engineering is required, with at least 5 years of experience.
Top 3 Skills:
