Senior Packaging Equipment Engineer - GMP Validation Lead

Akraya; New Albany (OH); On-site; USD 62,000 - 90,000; Full time

Job summary

Akraya is seeking a hands-on engineer to provide technical support for highly automated GMP packaging equipment in a commercial GMP environment. You will characterize, commission, qualify, validate, and document equipment, with rotations and potential international travel as needed.

You will lead commissioning, qualification, and validation activities, author GMP documentation, and troubleshoot equipment performance.

Qualifications

• GMP knowledge and experience is required.
• Hands-on with automated GMP packaging equipment.
• Experience authoring GMP documentation and validation protocols.
• Strong troubleshooting of packaging equipment performance issues.
• Familiarity with KNEAT or Veeva tools is a plus.

Responsibilities

• Provide direct technical support for automated GMP packaging equipment.
• Lead commissioning, qualification, and validation activities.
• Author and manage GMP technical documentation.
• Troubleshoot and resolve equipment performance issues.
• Implement process improvements for efficiency and reliability.

Skills

GMP

Packaging

Validation

Tech Writing

KNEAT/Veeva

Troubleshooting

Tools

KNEAT

Veeva

Job description

Akraya is seeking a hands-on engineer to provide technical support for highly automated GMP packaging equipment in a commercial GMP environment. You will characterize, commission, qualify, validate, and document equipment, with rotations and potential international travel as needed.

You will lead commissioning, qualification, and validation activities, author GMP documentation, and troubleshoot equipment performance.