VALIDATION/PROJECT ENGINEER (ONSITE)
- Contractor
- Full-Time
- MICHIGAN
- Splintpharma
- Prefferd visa: OPT, CPT, F1, H4, L2, Have H1 Visa, Need H1 Visa, EAD, TN Permit Holder, Green Card Holder, US Citizen
- Posted 2 years ago – Accepting applications
-
Offerd Salary $ 25 - $ 45
-
Required Position 2-4 hires
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Experience 0-3 Years Required
Assignment Overview:
Our client is a leading biopharmaceutical contract manufacturer who recently won a large project for a globally distinguished pharmaceutical company. They are currently need a validation engineering consultant to support them with commissioning, qualification, and validation efforts for an HVAC project.
Our consultants will be responsible for working closely with the client’s validation, manufacturing, and quality teams to ensure that all commissioning, qualification, and validation activities are completed correctly. This consultant will function as a project engineer to ensure that the client’s internal team and HVAC supplier are working in an efficient manner. He/she will write the URS, send bids out to vendors, and support documentation.
This project will give our consultant the opportunity to work with a unique set of pharmaceutical manufacturing technologies, while having a direct impact on the development and commercialization of COVID-19 therapies.
Technical Must Haves:
5+ years of validation engineering experience (pharma/biopharma)
Experience writing and executing IQ/OQ/PQ for HVAC and utilities
Experience writing HVAC URS
Experience with sterile fill finish
Experience validating manufacturing lines
Experience reviewing and revising SOPs
Must be able to be onsite for the duration of the assignment
Assignment Overview:
Our client is a leading biopharmaceutical contract manufacturer who recently won a large project for a globally distinguished pharmaceutical company. They are currently need a validation engineering consultant to support them with commissioning, qualification, and validation efforts for an HVAC project.
Our consultants will be responsible for working closely with the client’s validation, manufacturing, and quality teams to ensure that all commissioning, qualification, and validation activities are completed correctly. This consultant will function as a project engineer to ensure that the client’s internal team and HVAC supplier are working in an efficient manner. He/she will write the URS, send bids out to vendors, and support documentation.
This project will give our consultant the opportunity to work with a unique set of pharmaceutical manufacturing technologies, while having a direct impact on the development and commercialization of COVID-19 therapies.
Technical Must Haves:
5+ years of validation engineering experience (pharma/biopharma)
Experience writing and executing IQ/OQ/PQ for HVAC and utilities
Experience writing HVAC URS
Experience with sterile fill finish
Experience validating manufacturing lines
Experience reviewing and revising SOPs
Must be able to be onsite for the duration of the assignment