Junior GMP OOS Investigator - Process Engineer (Hybrid)

Sokolservices; Northern (KY); Hybrid; USD 37,000 - 40,000; Full time

Benefits offered by this job

Health insurance

Holiday pay

401(k) program

Referral bonus

Right to hire

Job summary

Sokolservices is seeking a Junior MSAT Process Engineer to support Manufacturing Science and Technology activities with a focus on Out-of-Specification (OOS) investigations in a GMP-regulated manufacturing setting. Responsibilities include reviewing batch records, process data, equipment logs, and analytical results to develop investigation conclusions and technical rationale.

The role requires strong GMP experience, formal education in a technical discipline, and the ability to work across QA,

Qualifications

• 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.

Responsibilities

• Support OOS investigations by reviewing batch records, process data, equipment logs, and analytical results.
• Develop technically sound investigation findings and conclusions.
• Take ownership of investigations as assigned and present findings with technical rationale.
• Work cross-functionally with QA, QC, Manufacturing and Engineering to gather data and align on scope.
• Present findings to cross-functional teams and management.

Skills

GMP experience

cGMP manufacturing

Technical writing

Problem solving

Analytical skills

Cross-functional collaboration

Communication skills

Teamwork

Education

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

Tools

Electronic data systems

Job description

Sokolservices is seeking a Junior MSAT Process Engineer to support Manufacturing Science and Technology activities with a focus on Out-of-Specification (OOS) investigations in a GMP-regulated manufacturing setting. Responsibilities include reviewing batch records, process data, equipment logs, and analytical results to develop investigation conclusions and technical rationale.

The role requires strong GMP experience, formal education in a technical discipline, and the ability to work across QA,