Senior CQV & Validation Engineer - GMP Lab Lead (Onsite)

Akraya, Inc.; New Albany (OH); On-site; USD 108,886,000 - 123,213,000; Full time

Job summary

Akraya, Inc. is seeking a role focused on validation, maintenance, and hands‑on support of laboratory equipment and diagnostic tools that support manufacturing and development activities. You will collaborate across departments to resolve issues, maintain inspection readiness, and manage validated systems lifecycles.

The role emphasizes cGMP compliance, data integrity, and strong ownership of laboratory utilities in a regulated environment.

Qualifications

• Hands‑on experience with laboratory validation and CQV.
• Direct experience in GMP laboratory operations and challenge kit management.
• Demonstrated ability to provide dynamic manufacturing support and technical ownership.

Responsibilities

• Lead validation strategies for laboratory systems and equipment.
• Manage the lifecycle and qualification of challenge kits.
• Oversee the 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 compliance

Laboratory equipment troubleshooting

Hands‑on diagnostics

Cross‑functional collaboration

Job description

Akraya, Inc. is seeking a role focused on validation, maintenance, and hands‑on support of laboratory equipment and diagnostic tools that support manufacturing and development activities. You will collaborate across departments to resolve issues, maintain inspection readiness, and manage validated systems lifecycles.

The role emphasizes cGMP compliance, data integrity, and strong ownership of laboratory utilities in a regulated environment.