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.
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