Process Hygiene Lead

About the role

AbbVie is looking for a Process Hygiene Lead in Singapore to lead and execute process hygiene activities across Biologics Manufacturing, covering Central Services, Cell Culture and Purification. The role acts as the process hygiene subject matter expert for Manufacturing, translating regulatory, network and site requirements into shop-floor controls, risk assessments, training and continuous improvement. It provides technical leadership, work coordination and coaching without formal people-management accountability.

Key responsibilities

• Lead contamination and cross-contamination FMEAs, operability studies, product change overs (PCOs), change plans and process hygiene assessments
• Lead process-hygiene investigations (contamination events, cleaning and microbial control deficiencies), support root-cause analysis, CAPA and timely closure
• Drive contamination risk reduction, continuous improvement and inspection-readiness initiatives
• Review routine and in-process metrics to spot leading indicators and emerging risks
• Assess aseptic techniques through Gemba observations, coach staff and drive follow-up actions
• Partner with QC on microbial and environmental monitoring data, and with Manufacturing, Quality, Engineering, Facilities and Validation teams
• Translate regulations and standards into site procedures, controls, training and job aids, and update SOPs
• Deliver process hygiene training and coaching, maintain a strong shop-floor presence and communicate trends and risks to stakeholders

Required profile

• Bachelor's degree in Microbiology, Biology, Biotechnology, Chemical Engineering, Pharmacy or a related scientific/engineering discipline
• At least 7 years of experience in biologics/pharmaceutical manufacturing, aseptic processing, microbiology, quality or a related GMP environment
• Experience leading technical initiatives and cross-functional teams without direct authority
• Experience supporting regulatory inspections or internal audits preferred

Required skills

• cGMP, contamination control, aseptic techniques, quality systems, investigations, CAPA, change control and SOP governance
• FMEAs, operability/risk assessments, data trending and Gemba assessments
• Technical writing, training, coaching, facilitation and stakeholder communication
• Basic statistical tools and environmental/process monitoring data analysis preferred