- Drafting and documenting validation protocols in accordance with FDA regulations, including but not limited to User Requirements Specifications (URS), Failure Mode and Effects Analysis (FMEA), Software Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Design Qualifications (DQ).
- Collaborating closely with site engineers to ensure detailed engineering requirements are met throughout the validation process.
- Utilizing a V model validation approach to ensure comprehensive validation coverage.
- Partnering with relevant stakeholders to obtain approval for validation documentation.
- Supporting the execution and sign-off of validation documentation for equipment validation processes.
- Proficiently using tools such as M-Files and MS Project to manage documentation and project timelines.
- Bachelor's degree in Engineering or related field.
- Seeking 5+ years of experience in a Validation role, ideally within FDA regulated industries, preferably in the medical device or pharmaceutical sector.
- Strong understanding of FDA regulations and standards, particularly 21 CFR Part 11 compliance.
- Experience with drafting and documenting validation protocols, including URS, FMEA, SIA, DQ, and IQ/OQ/PQ documentation.
- Familiarity with M-Files and MS Project is advantageous.
- Excellent communication and collaboration skills, with the ability to work effectively in a team environment.
- Detail-oriented with a commitment to ensuring accuracy and compliance in validation processes.
- Ability to adapt to changing priorities and manage multiple tasks concurrently.
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Validation Engineer - Columbus, United States - The Fountain Group
Description
Pay $66/HR to $78/HR
Currently seeking a Validation Engineer for a global, premiere healthcare leader with a portfolio of life-changing technologies and products in diagnostics, medical devices, nutritionals and branded generic medicines.
This is an onsite position in Columbus, OH – NOT a remote opportunity. W2 only, no C2C entertained.
We are currently seeking a dedicated Validation Engineer to join our team. As a Validation Engineer, you will play a crucial role in ensuring compliance with FDA regulations and standards, particularly focusing on 21 CFR Part 11 compliance. Your primary responsibilities will include drafting, documenting, and executing validation protocols for new process equipment and packaging equipment, with a strong emphasis on sterilization and compliance.
Key Responsibilities:
Qualifications:
