Senior Process Development/CQV Engineer - Laboratory Instruments/Equipment

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

Primary Skills

Laboratory Equipment validation [advanced], CQV [advanced], GMP compliance [advanced], Laboratory Equipment troubleshooting [advanced], Hands‑on diagnostics [advanced], Cross‑functional collaboration [advanced]

Contract Type: W2 Contract Duration: 12+ Months Location: New Albany, OH (Fully Onsite) Pay Range: $38.00 - $43.00 Per Hour

Job Summary

This role is critical for ensuring the operational readiness and compliance of the process development laboratory. You will be responsible for the validation, maintenance, and hands‑on support of laboratory equipment and diagnostic tools that underpin manufacturing and development activities. A key aspect involves partnering with various departments to resolve issues, maintain inspection readiness, and manage the lifecycle of validated systems.

Key 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.

Must‑Have Skills

• 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.
• This role requires experience in a regulated manufacturing or development environment, with a strong preference for backgrounds in engineering or life sciences.