MSAT Process Engineer for OOS Investigations (Hybrid, GMP)

SOKOL GxP Services; United States; Hybrid; USD 50,000 - 52,000; Full time

Benefits offered by this job

Health insurance

Holiday pay

401(k) program

Employee referral bonus

Direct-hire option

Job summary

SOKOL GxP Services is seeking a Junior MSAT Process Engineer to support OOS investigations within a GMP-regulated manufacturing environment. You will review batch records, process data, and analytical results to help develop sound investigation findings and conclusions.

The role requires collaboration across Quality Assurance, Quality Control, Manufacturing, and Engineering, with investigation ownership as appropriate and an on-site/hybrid work arrangement in Devens, MA.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or related
• 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 analytical and critical-thinking skills

Responsibilities

• Review batch records, process data, equipment logs, and analytical results
• Develop technically sound investigation findings and conclusions
• Investigation ownership may be assigned as appropriate
• Present investigation findings and technical rationale to cross-functional teams and management

Skills

GMP experience

Analytical thinking

Problem-solving

Technical writing

Cross-functional collaboration

Presentation skills

Electronic data systems

Education

Bachelor's degree in Chemical Engineering, Biochemical Engineering, Chemistry, or related

Job description

SOKOL GxP Services is seeking a Junior MSAT Process Engineer to support OOS investigations within a GMP-regulated manufacturing environment. You will review batch records, process data, and analytical results to help develop sound investigation findings and conclusions.

The role requires collaboration across Quality Assurance, Quality Control, Manufacturing, and Engineering, with investigation ownership as appropriate and an on-site/hybrid work arrangement in Devens, MA.