Process Hygiene Manager, Biologics Manufacturing

About the role

AbbVie is looking for a Process Hygiene Manager for its Biologics Manufacturing site in Singapore. The role provides site-wide leadership and governance for the Process Hygiene program across Central Services, Cell Culture and Purification, ensuring manufacturing practices, contamination-control systems and process hygiene standards comply with cGMP and regulatory requirements. It also covers governance of facility cleaning and disinfection and the integration of microbial and environmental monitoring into the contamination-control program.

Key responsibilities

• Develop and maintain the site Process Hygiene strategy, governance model, priorities and roadmap, and act as the main link to the global Process Hygiene organization
• Own site reporting and management reviews, including leading indicators, trends, operability studies, standards adherence, investigations, projects and audit readiness
• Govern cleaning and disinfection standards, frequency and performance review across the biologics manufacturing streams
• Review microbial and environmental monitoring data, organism identification, excursions and adverse trends and incorporate them into risk assessments and reporting
• Provide governance for contamination and cross-contamination FMEAs, operability studies, aseptic technique best practices, PCOs, change plans and other risk assessments
• Ensure timely adoption of regulations and network requirements, and sponsor updates to procedures, training and controls
• Act as subject matter expert for contamination, bioburden, sterility, environmental monitoring and process hygiene investigations, including root cause, CAPA and systemic risk assessment
• Establish a consistent Gemba and shop-floor engagement framework, and represent Process Hygiene at regulatory inspections, internal audits and site governance forums
• Lead cross-functional initiatives and projects, coach and develop the Process Hygiene team, and build strong cross-functional relationships

Required profile

• Bachelor's degree in Microbiology, Biology, Biotechnology, Chemical Engineering, Pharmacy or a related scientific/engineering discipline
• 10+ years of related experience, including at least 10 years in biologics/pharmaceutical manufacturing, aseptic processing, microbiology, quality or a related GMP-regulated environment
• Demonstrated people leadership, strategic planning, program governance and cross-functional project leadership
• Ability to interpret complex technical and compliance information, make risk-based decisions with limited oversight and communicate to senior leadership

Required skills

• Strong knowledge of cGMP, contamination control, aseptic processing, quality systems, investigations, CAPA, change control and regulatory inspection expectations
• Experience leading FMEAs, operability or risk studies, data trending and implementing regulatory or network standards
• Working knowledge of statistical tools and environmental/process-monitoring data analysis preferred