Process Validation Specialist / Hybrid / Fargo, ND
Fargo, North Dakota
Contract
$50/hr - $100/hr
Our client is Large Contract Development and Manufacturing Organization based in Fargo, ND searching for a Process Validation Specialist.
The ideal candidate has a strong understanding of the full process validation lifecycle, specifically for biologics products. They are looking for someone who can work independently and manage multiple process validation projects at the same time. This person will be responsible for developing Validation Master Plans, PPQ, pFMEA Risk Assessments, and Data Analysis/Trend Analysis.
Contract Duration: 6 Months with the possibility of extension
Required Skills & Experience
- Strong Understanding of Process Validation Lifecycle
- Background in Biologics Products (both Drug Substance & Drug Product)
- Strong experience with PPQ, Process Characterization, pFMEA Risk Assessments, Data Analysis / Trend Analysis in Excel & JMP, Protocol Generation
- 5-10 years working in Process Development / Validation
- Ability to work independently
- Ability to manage multiple projects concurrently
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.
As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.
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