Aseptic Process Validation Associate - Hybrid (Devens)

SOKOL GxP Services; Ayer (MA); Hybrid; USD 43.000 - 47.000; Vollzeit

Benefits dieser Stelle

Health insurance with dental andVision

Holiday pay

401(k) program

Employee referral bonus program

Client retains right to hire

Zusammenfassung

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

The candidate will assist with lifecycle management changes, ensure cGMP compliance, and collaborate with MS&T teams to support validation efforts.

Qualifikationen

• Bachelor's degree in Science, Engineering, Biochemistry, or a related discipline.
• Minimum 2 years of experience in biopharmaceutical operations or equivalent.
• Excellent technical writing skills, including SOPs, protocols, reports, change controls.
• Knowledge of cGMP requirements and relevant biopharmaceutical or cell therapy regulations.
• Excellent written and verbal communication skills.
• Authorization to work in the United States without visa sponsorship.

Aufgaben

• 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 requirements and maintain inspection readiness.
• Collaborate with MS&T teams to support validation activities.

Kenntnisse

Technical writing

Communication

Ausbildung

Bachelor's degree in Science or related

Jobbeschreibung

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

The candidate will assist with lifecycle management changes, ensure cGMP compliance, and collaborate with MS&T teams to support validation efforts.