MSAT Process Engineer: Drug Manufacturing SME

ElevateBio; Pittsburgh (Allegheny County); On-site; USD 90,000 - 150,000; Full time

Job summary

ElevateBio is seeking a Process Engineer for MSAT to provide process science support for GMP manufacturing, technology transfers, development studies, and validation in a matrixed team. You will act as SME for manufacturing processes and help author technical reports and change controls to meet regulatory requirements.

In this role you will collaborate with Process Development, Manufacturing, Regulatory Sciences and Quality to enable successful tech transfers, process validation and data-driven

Qualifications

• BS or MS in Biochemical/Chemical Engineering, Biotechnology, Chemistry or related field with 5+ years (BS) / 3+ years (MS) of relevant experience
• Experience with pharmaceutical/biotech manufacturing and aseptic processing
• Regulatory knowledge: cGMP, quality systems, and documentation

Responsibilities

• Provide process science support for GMP manufacturing, tech transfers, development studies, characterization, validation
• Act as SME for manufacturing processes and contribute to documentation, change controls, and regulatory submissions
• Collaborate cross-functionally to enable technology transfers and process validation
• Perform root-cause analysis, design experiments, and analyze data to drive improvements

Skills

Process Engineering

cGMP

Technology Transfer

Root Cause Analysis

Data Analysis

Technical Writing

Cross-Functional Teamwork

Statistical Analysis

Education

BS in Biochemical Engineering

MS in Biochemical Engineering

Tools

LOVO

Sepax

Rotea

CliniMACs

Job description

ElevateBio is seeking a Process Engineer for MSAT to provide process science support for GMP manufacturing, technology transfers, development studies, and validation in a matrixed team. You will act as SME for manufacturing processes and help author technical reports and change controls to meet regulatory requirements.

In this role you will collaborate with Process Development, Manufacturing, Regulatory Sciences and Quality to enable successful tech transfers, process validation and data-driven