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: $27.30–$29.30;
• 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.
Requirements
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.
Benefits
- 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.
Skills 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 and ability to work cross-functionally with Quality, Manufacturing, and Engineering stakeholders
- Authorization to work in the United States without visa sponsorship
- Pharmaceutical or biopharmaceutical industry background
- Strong technical understanding of cell therapy manufacturing processes
What We Do
SOKOL GxP Services is a specialized firm providing Commissioning, Qualification, and Validation (CQV) services to the pharmaceutical, biotech, and cell therapy industries. They focus on quality-driven, agile, and lean operational support to ensure regulatory compliance and inspection readiness. Additionally, they operate the SOKOL GxP Academy, which provides training in GMP fundamentals and professional development to support the life sciences workforce.
