Senior Packaging Validation Engineer, Biotech GMP Final Drug Product; JP
Listed on 2025-10-18
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Engineering
Quality Engineering, Packaging Engineer, Process Engineer, Validation Engineer
Job Title:
Senior Packaging Validation Engineer, Biotech GMP Final Drug Product (JP14454)
Location: New Albany, OH 43054
Business Unit: Site Process Development
Employment Type: Contract
Duration: 2+ years with possible extension or conversion to FTE
Rate: $53 - $63/hour (DOE) - W2 with benefits
Posting Date: 8/28/2025
Overview3 Key Consulting is hiring! We are recruiting a Senior Validation Engineer for a consulting engagement with our client, a leading global biotechnology company.
Position DetailsThe Senior Validation Engineer reports to the Sr. Manager of Validation and applies advanced engineering and scientific principles to support GMP Final Drug Product (FDP) operations. The role requires travel (~10%) and onsite presence.
Responsibilities- Support development and implementation of automated and semi-automated combination product assembly equipment.
- Manage and apply technical expertise in validation of combination products.
- Support packaging commissioning & qualification activities.
- Provide technical operations support for process improvements and equipment performance.
- Communicate effectively with stakeholders across the Ohio site and network.
- Experience with high-speed, automated secondary packaging operations.
- Knowledge of validation of equipment such as PFS assembly, cartoners, vision systems.
- Experience in protocol writing and execution.
- Ability to manage multiple projects.
- Strong communication skills and innovative mindset.
- Experience with Kneat;
Minitab is a plus.
- Packaging validation experience.
- Knowledge of packaging equipment.
- Protocol generation and execution.
- Writing and executing validation protocols.
Doctorate OR Masters with 2+ years, Bachelors with 4+ years, Associates with 8+ years of experience.
Additional InformationPosition open to support team workload. Interview process includes initial screening and final panel. Send resumes to Visit our website for other opportunities.
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