Sr. Packaging Equipment Validation Engineer
- Columbus, OH
- Permanent
- Full-time
- Lead packaging equipment validation activities including the development and execution of IQ, OQ, PQ protocols and traceability matrices.
- Coordinate and manage validation projects in alignment with client schedules and expectations.
- Oversee Junior Validation Engineers, providing technical guidance and ensuring quality of work.
- Ensure full compliance with FDA regulations, cGMP, and industry best practices throughout validation activities.
- Collaborate with cross-functional teams including Engineering, QA, and Operations to support successful commissioning and qualification.
- Generate, execute, and review validation documentation, protocols, and reports.
- Support packaging equipment field execution and troubleshoot issues during qualification phases.
- Participate in project planning meetings and provide regular status updates to client leads and internal stakeholders.
- Identify and mitigate project risks, proactively ensuring validation milestones are met on time.
- Adapt to changing schedules and priorities, including the ability to work extended shifts, weekends, and travel on short notice when required.
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- Minimum 5 years of experience in equipment validation within biotech, pharmaceutical, or medical device industries.
- Proven expertise in validation lifecycle documents (IQ/OQ/PQ, protocols, traceability matrix, etc.).
- Solid understanding of FDA validation guidelines, cGMP, and regulatory requirements.
- Experience working in regulated manufacturing environments with complex, automated packaging systems.
- Strong technical writing and documentation skills.
- Ability to work independently, manage priorities, and lead project segments.
- Excellent interpersonal and communication skills.
- Willingness to work flexible hours and travel as needed (up to 25%).