Aseptic Process Validation Associate – Hybrid

SOKOL GxP Services; Harvard (MA); Híbrido; USD 43 000 - 47 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health insurance

Dental and vision options

401(k) program

Employee referral bonus

Resumo da oferta

SOKOL GxP Services is seeking an Assistant Process Engineer to support process validation activities at a cell therapy manufacturing facility in Devens, MA. The role focuses on aseptic process simulations and validations (APS/APV), lifecycle changes, and preparing validation protocols, reports, and summaries.

Required: Bachelor's degree in Science/Engineering/Biochemistry; at least 2 years in biopharmaceutical operations; strong technical writing; knowledge of cGMP; US work authorization.

Qualificações

• Bachelor's degree in Science, Engineering, Biochemistry, or related discipline.
• Excellent technical writing skills (proposals, SOPs, protocols, change controls).
• Knowledge of cGMP requirements and biopharmaceutical regulations.

Responsabilidades

• Support process validation activities including aseptic process simulations and validations.
• Prepare technical protocols, validation reports and study summaries.
• Support implementation of process lifecycle management changes.
• Ensure compliance with cGMP and maintain inspection readiness.
• Collaborate with MS&T teams to support validation activities.

Formação académica

Bachelor's degree in Science/Engineering/Biochemistry

Descrição da oferta de emprego

SOKOL GxP Services is seeking an Assistant Process Engineer to support process validation activities at a cell therapy manufacturing facility in Devens, MA. The role focuses on aseptic process simulations and validations (APS/APV), lifecycle changes, and preparing validation protocols, reports, and summaries.

Required: Bachelor's degree in Science/Engineering/Biochemistry; at least 2 years in biopharmaceutical operations; strong technical writing; knowledge of cGMP; US work authorization.