- Drafting, validation, and documentation for equipment validation
- FDA compliance with packaging and processing equipment
- Design qualifications, functional requirements, operations and performance qualifications
- Develop and execute validation protocols and reports for equipment, processes, and systems.
- Perform risk assessments and impact analyses to identify potential validation issues.
- Provide technical support to cross-functional teams during the validation process.
- Review and approve validation documentation, ensuring compliance with regulatory requirements.
- Identify opportunities for process improvements and recommend corrective actions.
- Collaborate with internal and external stakeholders to ensure validation activities are completed on time and within budget.
- Maintain up-to-date knowledge of regulatory requirements and industry best practices.
- Bachelor's degree in Science or Engineering fields (or equivalent experience).
- Minimum 5 years of experience supporting validation programs in a regulated industry.
- Proficiency in Microsoft Office, excel, and project
- Experience in an FDA-regulated industry
- Validation, document generation, and compliance experience
- Experience with 21 CFR Part 11
- Strong attention to detail and ability to perform critical analysis of situations.
- Good follow-up skills and ability to provide recommendations for process improvements.
- 12-month contract
- FT, M-F 40hr/week
- Pay Rate: $65-70/HR ($130-140K Annually)
- Onsite in Columbus, Ohio
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Validation Engineer - Columbus, United States - GForce Life Sciences
Description
Validation Engineer III – Columbus Ohio
Must be able to work on a W2
Job Title: Validation Engineer III
Job Description: We are seeking a highly motivated and experienced Validation Engineer Level 3 to join our dynamic team. The successful candidate will be responsible for supporting validation programs and ensuring compliance with regulatory requirements. This role requires a detail-oriented individual with strong analytical skills and the ability to work independently with structured guidance.
Responsibilities:
Qualifications:
Term & Start