Senior Process Engineer (New Product Introduction)

Pfizer Singapore is looking for an experienced and driven Senior Process Engineer (NPI) to support the introduction and commercialization of new API products at our manufacturing site.

This role requires a strong technical expert with proven experience in process troubleshooting, deviation investigation, and technology transfer in a GMP-regulated environment. The successful candidate will work closely with cross-functional teams to ensure smooth project execution while meeting compliance, safety, and delivery timelines.

Key Responsibilities

1) Technology Transfer & NPI Execution

• Lead and support end-to-end technology transfer activities from R&D or global sites into the Singapore manufacturing plant.
• Perform process and equipment gap assessments, and define required modifications for successful scale-up and commercialization.
• Develop and review manufacturing instructions, SOPs, manual batch records, and process documentation in compliance with GMP.
• Collaborate closely with Technical Services, Production, Quality, Engineering, Supply Chain and EHS to ensure successful process implementation.
• Drive process readiness, and validation activities.
• Ensure all project milestones and deliverables are met in alignment with site and global timelines.

2) Process Troubleshooting & Investigation

• Act as the technical lead for process troubleshooting during manufacturing campaigns.
• Lead deviation investigations, including root cause analysis and impact assessment.
• Define and implement effective CAPA to prevent recurrence.
• Support batch disposition by ensuring process understanding and data integrity.

3) Continuous Improvement & Compliance

• Identify and implement process improvements to enhance yield, quality, and robustness.
• Apply Lean principles and data-driven methodologies to optimize processes.
• Ensure strict adherence to cGMP, HSA regulatory requirements, and Pfizer Quality Standards.
• Promote a strong safety culture and ensure EHS compliance at all times.

4) Automation & Process Control

• Support development and optimization of process control strategies and deltaV recipes.
• Troubleshoot and enhance automation systems in collaboration with Automation.

5) Project & Stakeholder Management

• Manage project activities, timelines, and resources to ensure on-time delivery of NPI projects.
• Work effectively with global stakeholders across different time zones.
• Provide clear communication on project progress, risks, and mitigation plans.
• Mentor junior engineers and support capability building within the team.

Qualifications

Minimum Requirements

• Degree in Chemical Engineering or Chemistry (or related discipline).
• 5–10 years of relevant experience in pharmaceutical/API manufacturing or chemical processing industry.
• Strong experience in NPI, technology transfer, or process scale-up.
• Proven track record in process troubleshooting and deviation investigation (RCA/CAPA).
• Good understanding of cGMP and regulatory requirements (HSA/FDA/EMA).
• Strong communication and stakeholder management skills.
• Demonstrated project management capabilities with ability to meet tight timelines.

Preferred Requirements

• Experience working in API manufacturing environments in Singapore.
• Familiarity with automation systems (e.g., Emerson deltaV).
• Knowledge of process validation, risk assessment tools (FMEA), and lifecycle management.
• Experience working with global teams / tech transfer across sites.

Key Competencies

• Strong analytical and structured problem-solving skills
• High ownership and accountability
• Results-oriented with strong sense of urgency
• Detail-oriented with strong organisational skills

Why Join Pfizer Singapore

• Be part of a leading global pharmaceutical company with a strong presence in Singapore
• Work on cutting-edge API products and global launches
• Collaborative and diverse work environment with strong career development opportunities
• Exposure to global stakeholders and advanced manufacturing technologies

  
Work Location Assignment: On Premise

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.


Engineering