Process Engineer II - Upstream Manufacturing

Overview

This role focuses on supporting and leading troubleshooting activities related to upstream manufacturing operations and process/product issues. The Process Engineer II acts as a technical subject matter expert (SME) to resolve process challenges, conduct root cause analyses, and evaluate process impacts for investigations. The position involves supporting technology assessments, planning and executing process enhancements, and participating in global manufacturing science initiatives. Responsibilities also include managing site manufacturing science activities such as continuous process verification (CPV), technology transfer of new products, and process monitoring and trend analysis.

Key Duties

• Facilitate planning and execution of process investigation tasks including impact assessments and root cause analyses involving cross-functional collaboration.
• Analyze process trends and monitor performance within the CPV framework; escalate and investigate deviations promptly.
• Lead process investigations to determine causes and develop/action corrective or preventive plans.
• Plan and execute projects aimed at process improvements and robustness enhancement.
• Lead or support cycle development for process parameters where applicable.
• Prepare and deliver process training materials to multidisciplinary teams.
• Initiate and manage change controls for process modifications and perform related impact assessments.
• Contribute technical insights for master batch record creation and revisions, including document reviews.
• Lead/support technology transfer involving new technologies and product introductions, ensuring alignment with project timelines and change control requirements.
• Continuously monitor and trend process performance as part of the CPV program; proactively investigate to uphold process robustness.
• Conduct risk assessments and draft technical transfer and process control strategy documents; update lifecycle documents accordingly.
• Author validation protocols and reports as necessary.
• Support regulatory audits, submissions, and responses.
• Contribute to global manufacturing sciences projects as scheduled.
• Adhere strictly to environmental, health, and safety (EHS) protocols.
• Demonstrate commitment to ethical conduct consistent with company Code of Conduct.
• Perform additional tasks as assigned by supervisors.

Qualifications and Experience

• Bachelor’s degree in Biochemistry, Chemistry, Chemical Engineering, Biotechnology, or Biochemical Engineering with 3-4 years of relevant experience, or Master’s degree with 2 years’ experience, or a fresh PhD in a related technical discipline.
• Practical exposure to cell culture or upstream/downstream manufacturing or development processes.
• Familiarity with current Good Manufacturing Practices (cGMP).

Skills and Competencies

• Deep technical understanding of biopharmaceutical process applications.
• Strong analytical capability to systematically evaluate issues, perform root cause analyses, and correlate effects.
• Effective communication skills.
• Enthusiastic learner.
• Team player comfortable working in matrix structures.
• Self-motivated and able to work independently.

Location and Employment Type

Based in Woodlands, Singapore. This is a full-time employee position working onsite.

Additional Information

By applying, candidates acknowledge that their application data will be processed in accordance with company privacy policies and affirm truthfulness of submitted information.