Lead Cleaning Validation Engineer – Pharma
Location - Devens, MA
Long Term Contract
Cleaning Validation SME on Biologic side
SUMMARY
The New Product Introduction (NPI) project aims to implement facility modifications for the tech transfer of one or more new products into the LSCC as well as further improvements that may be used to drive future enhancements in manufacturing throughput.
The selected candidate will lead the CIP / SIP portion of the NPI project.
In Short- Must have skills
- 5+ years Cleaning Validation (Lifecycle)
- CIP/SIP cycle development (not just execution)
- Biologics experience (not small molecules)
- Hands-on:
- Swab & rinse sampling
- Visual inspection
- Riboflavin studies
- Experience with:
- Bioreactors, process piping, transfer panels
- Autoclaves / glass washers (load patterns)
- DeltaV automation exposur
Good-to-Have (Adds Strong Value)
- Ellab ValSuite Pro
- ValGenesis
Mandatory Requirements:
Minimum 5 years of Cleaning Validation experience to include:
1. Hands-on experience taking rinse and swab samples and performing visual inspection.
2. Experience developing CIP and SIP cycles for process piping, transfer panels, and bioreactors.
3. Experience developing load patterns for autoclaves and parts / glass washers.
4. Experience with Delta V automation for CIP / SIP.
5. Hands on experience executing Riboflavin studies.
Preferred Requirements to include:
1. Experience using Ellab ValSuite Pro system
2. Experience using Valgenesis for electronic development/review of protocols and execution.
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