Process Engineer Biologics

Job Title: Process Engineer - Biologics

Location: Singapore
Industry: Biopharmaceutical / Biotechnology Manufacturing

Job Overview

We are seeking a Process Engineer - Biologics to support the development, optimization, and scale-up of biologics manufacturing processes. The successful candidate will play a key role in ensuring robust, efficient, and compliant upstream and downstream manufacturing processes for biologic products.

This role will collaborate closely with manufacturing, quality, and technical teams to improve process performance, troubleshoot production issues, and support technology transfer activities.

Key Responsibilities

Process Development & Optimization

• Support development and optimization of upstream and downstream biologics manufacturing processes.

• Monitor and analyze process performance to identify opportunities for improvement in yield, efficiency, and cost.

• Conduct process characterization, validation, and scale-up activities.

Manufacturing Support

• Provide technical support to GMP manufacturing operations.

• Troubleshoot process deviations, investigate root causes, and implement corrective actions.

• Support batch record review, deviation investigations, and CAPA implementation.

Technology Transfer

• Support process technology transfer from R&D to manufacturing or between manufacturing sites.

• Develop process documentation including process descriptions, SOPs, and technical reports.

Process Validation & Compliance

• Participate in process validation activities, including IQ/OQ/PQ.

• Ensure processes comply with GMP, regulatory, and quality requirements.

• Collaborate with Quality and Regulatory teams during audits and inspections.

Data Analysis & Continuous Improvement

• Analyze process data using statistical tools to drive continuous improvement initiatives.

• Support implementation of Lean, Six Sigma, or operational excellence programs.

Requirements

Education

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

Experience

• 3-8 years of experience in biologics or biopharmaceutical manufacturing.

• Experience with cell culture, fermentation, purification, or biologics processing.

• Experience supporting GMP manufacturing environments.

Technical Skills

• Knowledge of upstream (cell culture, bioreactors) or downstream processing (chromatography, filtration).

• Familiarity with process validation and technology transfer.

• Experience with data analysis and process optimization tools.

Preferred Qualifications

• Experience with monoclonal antibodies, vaccines, or recombinant proteins.

• Knowledge of regulatory guidelines (FDA, EMA, ICH).

• Experience with bioprocess equipment and automation systems.

Key Competencies

• Strong problem-solving and analytical skills

• Excellent cross-functional collaboration

• Ability to work in a fast-paced GMP manufacturing environment

• Strong documentation and communication skills