Aseptic Process Validation Specialist - Hybrid Role

SOKOL GxP Services; United States; Hybride; USD 43 000 - 47 000; Plein temps

Avantages offerts par ce poste

Health insurance (dental & vision)

Holiday pay

401(k) program

Employee referral bonus program

Direct-hire option for client

Résumé du poste

SOKOL GxP Services is seeking an MS&T Process Validation Specialist to support aseptic process simulations and validations at a cell therapy facility in Devens, MA. The role covers protocol and report preparation, along with lifecycle management changes to ensure cGMP compliance.

The position offers a hybrid work arrangement (50% onsite) with a 6-month contract term and potential extension, W-2 employment, and US work authorization. Hours are standard M–F, with up to 40 hours per week.

Qualifications

• 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, and change controls.
• Knowledge of cGMP requirements and applicable biopharmaceutical or cell therapy regulations.
• Excellent written and verbal communication skills.
• Authorization to work in the United States without visa sponsorship.

Responsabilités

• Support aseptic process simulations and validations (APS/APV).
• 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.

Connaissances

Technical writing

Communication

cGMP knowledge

Team collaboration

Regulatory knowledge

Formation

Bachelor's degree in Science/Engineering/Biochemistry

Outils

APS/APV

Description du poste

SOKOL GxP Services is seeking an MS&T Process Validation Specialist to support aseptic process simulations and validations at a cell therapy facility in Devens, MA. The role covers protocol and report preparation, along with lifecycle management changes to ensure cGMP compliance.

The position offers a hybrid work arrangement (50% onsite) with a 6-month contract term and potential extension, W-2 employment, and US work authorization. Hours are standard M–F, with up to 40 hours per week.