Assistant Process Engineer - MSAT

SOKOL GxP Services; Harvard (MA); Presencial; USD 48.000 - 52.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Dental insurance

Vision insurance

Holiday pay

401(k) plan

Employee referral bonus

Descripción de la vacante

SOKOL GxP Services is seeking a Junior MSAT Process Engineer to support GMP-driven OOS investigations. You will review batch records, process data, and analytical results, and help craft investigation findings with technical rationale.

Based in Devens, MA, this hybrid role requires strong GMP experience and collaboration with QA, QC, Manufacturing, and Engineering to deliver clear, data-driven conclusions.

Formación

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry or related technical discipline.
• 0-2 years of industry experience in GMP environments preferred.
• Experience with cGMP or cell therapy manufacturing is a plus.

Responsabilidades

• Support OOS investigations by reviewing batch records, data, logs, and results.
• Develop investigation findings and technical rationales for cross-functional teams.
• Present investigative outcomes to QA, QC, Manufacturing, and Engineering.

Conocimientos

GMP experience

Technical writing

Problem-solving

Analytical thinking

Communication

Cross-functional collaboration

Educación

Bachelor's degree in Chemical/Biochemical Engineering or Chemistry

Herramientas

Electronic data systems

Descripción del empleo

The Junior MSAT Process Engineer will support Manufacturing Science and Technology activities with a primary focus on Out-of-Specification (OOS) investigations within a GMP-regulated manufacturing environment. The role will support OOS investigations by reviewing batch records, process data, equipment logs, and analytical results and helping develop technically sound investigation findings and conclusions. Investigation ownership may be assigned as appropriate. The engineer will work cross-functionally with Quality Assurance, Quality Control, Manufacturing, and Engineering to gather data, align on investigation scope, and present investigation findings and technical rationale to cross-functional teams and management. Strong GMP experience is important for this position. Pharmaceutical or biopharmaceutical industry experience is preferred.

Position details:

• Hourly rate: $35.60-$37.60;
• Start date: October 19, 2026;
• Contract length: 6 months with possible extension;
• Location: Devens, MA 01434;
• Work arrangement: Hybrid, minimum 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 Chemical Engineering, Biochemical Engineering, Chemistry, or a related technical discipline;
• 0-2 years of industry experience;
• Strong GMP experience within an industry environment;
• cGMP or Cell Therapy manufacturing experience;
• Technical writing skills for authoring impact assessments and Out-of-Specification investigations;
• Strong problem-solving, troubleshooting, and presentation skills;
• Familiarity with GMP documentation and electronic data systems;
• Strong analytical and critical-thinking skills with attention to detail;
• Ability to work collaboratively in a fast-paced environment;
• Effective communication skills with the ability to work cross-functionally with Quality, Manufacturing, and Engineering stakeholders;
• Authorization to work in the United States without visa sponsorship.

Preferred:

• Pharmaceutical or biopharmaceutical industry background;
• Strong technical understanding of cell therapy manufacturing processes.

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.