CQV Engineer
- Contractor
- Full-Time
- Houston, TX
- Splintpharma
- Prefferd visa: OPT, CPT, F1, H4, Have H1 Visa, Need H1 Visa, EAD, TN Permit Holder, Green Card Holder, US Citizen
- Posted 3 years ago – Accepting applications
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Offerd Salary $ 30 - $ 35
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Required Position 2-4 hires
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Experience 1-3 Years Required
Job Opening for CQV Engineer Location: Houston, TX Project: Our Client is looking for a CQV Engineer to qualify various pieces of manufacturing equipment. This person should have experience with generating protocols for utilities, facilities, single-use equipment. Lab equipment qualification is a plus. Additionally, it is beneficial if this person has qualified autoclaves and Bioquell VHPs. They have vendor documentation however this person should have experience with documentation lifecycle. It will be a combination of both authoring and execution work. This person should also have had experience validating closed system drug substance manufacturing equipment. They will be working with systems integrated with bioreactors, cell columns and other lab equipment. For the most part it is GAP 3 systems, HPLCs, and some LIMS work. It is beneficial if they have NEAT experience. They will be responsible for risk assessments and associated documentation, process, and gap assessments as well. They should be able to generate URS, design specifications, trace matrix reports and IQ/OQ.
Job Opening for CQV Engineer Location: Houston, TX Project: Our Client is looking for a CQV Engineer to qualify various pieces of manufacturing equipment. This person should have experience with generating protocols for utilities, facilities, single-use equipment. Lab equipment qualification is a plus. Additionally, it is beneficial if this person has qualified autoclaves and Bioquell VHPs. They have vendor documentation however this person should have experience with documentation lifecycle. It will be a combination of both authoring and execution work. This person should also have had experience validating closed system drug substance manufacturing equipment. They will be working with systems integrated with bioreactors, cell columns and other lab equipment. For the most part it is GAP 3 systems, HPLCs, and some LIMS work. It is beneficial if they have NEAT experience. They will be responsible for risk assessments and associated documentation, process, and gap assessments as well. They should be able to generate URS, design specifications, trace matrix reports and IQ/OQ.