Process Validation Specialist - MS&T

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

Vantagens oferecidas por esta oferta de emprego

Health insurance with dental and visão

Holiday pay

401(k) program

Employee referral bonus program

Resumo da oferta

SOKOL GxP Services seeks an MS&T Process Validation Specialist to support aseptic process simulations and validations at a Devens, MA facility. You will prepare protocols, reports, and summaries, and assist with lifecycle management changes to ensure cGMP compliance.

This is a hybrid, 50% onsite contract role. Qualifications include a BS in Science/Engineering/Biochemistry, 2+ years in biopharma operations, excellent technical writing, and strong communication skills.

Qualificações

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

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.

Conhecimentos

Technical writing

cGMP knowledge

Verbal communication

Formação académica

Bachelor's degree in Science/Engineering/Biochemistry

Descrição da oferta de emprego

We are seeking an MS&T Process Validation Specialist to support process validation activities at a cell therapy manufacturing facility in Devens, MA. This role focuses on supporting aseptic process simulations and validations (APS/APV), process lifecycle management changes, and the preparation of technical documentation, including validation protocols, reports, and summaries. Key responsibilities: 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 Manufacturing Science and Technology (MS&T) teams to support validation activities.

Position details:

• Hourly rate: $31.40-$34.40;
• Contract length: 6 months with possible extension up to 2 years;
• Location: Devens, MA 01434;
• Work arrangement: Hybrid, 50% onsite;
• Schedule: Monday-Friday, normal business hours;
• Maximum hours: 40 hours per week;
• W-2 contract position;
• No C2C options;
• No visa sponsorship.

Required:

• 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 experience preparing SOPs, protocols, summary reports, and/or 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.

Preferred:

• Experience with aseptic techniques and processes;
• Experience with cleanroom gowning;
• Experience supporting process validation activities, including aseptic process simulations (APS/APV);
• Experience supporting process lifecycle management changes.

Benefits and Programs:

• Health insurance with dental and vision insurance options.
• Holiday pay.
• 401(k) program.
• Employee referral bonus program.

The client retains the right to hire the contractor directly.