Process Engineer

What You’ll Do

Technology Transfer

Lead and coordinate the full lifecycle of tech transfer from development to manufacturing.

Collaborate with cross-functional teams to ensure all process knowledge and documentation are effectively communicated to the CMO.

Conduct facility fit assessments and system walk-downs to validate equipment and process readiness.

Process Engineering

Manage upstream processes, particularly mammalian cell culture at 2000L scale in single-use or stainless-steel bioreactors.

Oversee downstream purification operations including chromatography, ultrafiltration, and sterile filtration.

Support implementation of PAT (Process Analytical Technology) tools to enable real-time process monitoring and control.

GMP and Validation

Draft and execute IQ/OQ/PQ protocols for new or transferred equipment and systems.

Support QA in handling change controls, deviations, and CAPAs aligned with FDA and ICH guidelines.

Ensure compliance with all applicable cGMP regulations and internal quality systems.

Data & Documentation

Review and analyze process data to identify trends, troubleshoot issues, and support continuous improvement.

Prepare high-quality documentation including SOPs, validation reports, and batch records.

Cross-functional Collaboration

Act as a liaison between internal technical teams and external CMOs to ensure alignment on project deliverables.

Participate in joint project planning, risk assessments, and technical discussions.

Required Qualifications

Bachelor’s or Master’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field.

Minimum 5 years of experience in process engineering within the biopharmaceutical industry, with hands-on experience in mAb manufacturing.

Direct experience in technology transfer to CMOs.

Strong understanding of GMP requirements and bioprocess validation.

Proficient in working with large-scale bioreactors (2000L) and downstream unit operations.

Preferred Qualifications

Familiarity with single-use technologies and disposable bioprocessing systems.

Knowledge of regulatory submissions (e.g., IND, BLA).

Experience with statistical tools for process monitoring and optimization (e.g., JMP, Minitab).