0020V Lead Cleaning Validation Engineer
Devens, MA
Contracted
Mid Level
0020V Lead Validation Engineer (Pharma)
Please contact Amanda Mazza, [email protected]
**Cleaning Validation SME***
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.
Mandatory Requirements:
7-10 years of relevant Validation Experience within pharma / biologics.
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.
LOCATION
On-site in Devens, MA
EMPLOYMENT
January 1, 2026 start date – 1 year assignment + potential extension- Competitive C2C
Please contact Amanda Mazza, [email protected]
**Cleaning Validation SME***
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.
Mandatory Requirements:
7-10 years of relevant Validation Experience within pharma / biologics.
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.
LOCATION
On-site in Devens, MA
EMPLOYMENT
January 1, 2026 start date – 1 year assignment + potential extension- Competitive C2C
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