About the Role
The client needs additional help to support the qualification of a new building containing approximately 10 clean rooms and large volume lyophilization equipment/systems. The engineer will help with drafting user requirement specifications, writing SOPs, preparing qualification documentation package to be handed over to operations team, performing IQ/OQ activities and/or overseeing qualification activities at suppliers. The cleanrooms are Class C (EU GMP Grade C, ISO 7/8) used for making large volume GMP API production and are performing high volume lyophilization (tray loaded / bulk freeze drying).
Requirements:
- A minimum of 3-5 years qualification experience in biopharmaceutical manufacturing
- Previous experience qualifying clean rooms and/or lyophilizers
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