Process Engineer

Key Responsibilities:

Technology Transfer & Facility Readiness:

Lead end-to-end technology transfer of mAb processes to CMO partners.

Conduct facility fit and system walk-downs to assess infrastructure readiness.

Develop and manage comprehensive tech transfer documentation.

Process Engineering (Upstream & Downstream):

Oversee upstream operations, including large-scale mammalian cell culture in 2000L bioreactors.

Manage downstream processes such as chromatography and filtration.

Utilize Process Analytical Technologies (PAT) for real-time process monitoring.

GMP Compliance & Quality Assurance:

Develop and execute validation protocols (IQ/OQ/PQ) for equipment and processes.

Manage change controls, deviations, and CAPA in partnership with QA teams.

Ensure alignment with FDA regulations and current Good Manufacturing Practices (cGMP).

Data Analysis & Documentation:

Analyze process data to ensure process robustness and product quality.

Author and review technical documentation: batch records, SOPs, validation reports.

Cross-Functional Collaboration:

Interface with CMOs, internal teams, and external vendors to align project deliverables.

Participate in technical discussions, issue resolution, and project planning meetings.

Required Qualifications:

Minimum 5 years of experience in process engineering within the biopharmaceutical sector.

Demonstrated success in technology transfer of mAb products to CMOs.

Expertise with large-scale bioreactors (2000L) and downstream purification.

In-depth knowledge of GMP regulations, validation, and quality systems.

Strong analytical and problem-solving skills.

Excellent communication, teamwork, and project management abilities.