Senior Process Development/CQV Engineer - Laboratory Instruments/Equipment - 26-02922

Akraya; New Albany (OH); Vor Ort; USD 52.000 - 59.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Laboratory validation

CQV

GMP operations

Jobbeschreibung

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 #LP

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.