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Senior Packaging Validation Engineer, Biotech GMP Final Drug Product (JP14454)
Senior Packaging Validation Engineer, Biotech GMP Final Drug Product (JP14454)3key Consulting, Inc. • New Albany, OH, US
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Senior Packaging Validation Engineer, Biotech GMP Final Drug Product (JP14454)

Senior Packaging Validation Engineer, Biotech GMP Final Drug Product (JP14454)

3key Consulting, Inc. • New Albany, OH, US
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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

Overview

3 Key Consulting is hiring! We are recruiting a Senior Validation Engineer for a consulting engagement with our client, a leading global biotechnology company.

Position Details

The 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.

Qualifications

  • 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.

    • Key Skills

  • Packaging validation experience.
  • Knowledge of packaging equipment.
  • Protocol generation and execution.

    • Daily Responsibilities

  • Writing and executing validation protocols.

    • Qualifications

    Doctorate OR Masters with 2+ years, Bachelors with 4+ years, Associates with 8+ years of experience.

    Additional Information

    Position open to support team workload. Interview process includes initial screening and final panel. Send resumes to recruiting@3keyconsulting.com. Visit our website for other opportunities.

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    Validation Engineer • New Albany, OH, US