Onsite CQV Lab Validation Engineer – GMP & PD

Seniorlivingsuncity; New Albany (OH); On-site; USD 52,000 - 59,000; Full time

Job summary

Akraya, Inc. in New Albany, OH is seeking a Lab Equipment Validation Specialist to ensure the operational readiness and compliance of the process development laboratory.

You will validate, maintain, and provide hands-on support for laboratory equipment and diagnostic tools that underpin manufacturing and development activities. A key aspect is partnering with multiple departments to resolve issues, maintain inspection readiness, and manage the lifecycle of validated systems in a regulated

Qualifications

• Hands-on experience with laboratory validation and CQV.
• Direct GMP laboratory operations and challenge kit management experience.
• Experience in regulated manufacturing or development environments; engineering or life sciences backgrounds preferred.

Responsibilities

• Lead validation strategies for laboratory systems and equipment.
• Manage lifecycle and qualification of challenge kits.
• Oversee daily operation and readiness of PD lab spaces.
• Conduct preliminary diagnostic assessments for manufacturing issues.
• Ensure alignment with cGMP regulations and data integrity standards.

Skills

Laboratory validation

CQV

GMP operations

Job description

Akraya, Inc. in New Albany, OH is seeking a Lab Equipment Validation Specialist to ensure the operational readiness and compliance of the process development laboratory.

You will validate, maintain, and provide hands-on support for laboratory equipment and diagnostic tools that underpin manufacturing and development activities. A key aspect is partnering with multiple departments to resolve issues, maintain inspection readiness, and manage the lifecycle of validated systems in a regulated