Process Hygiene Lead, Biologics Manufacturing

About the role

AbbVie is looking for a Process Hygiene Lead to cover Biologics Manufacturing, including Central Services, Cell Culture and Purification. The role acts as the subject matter expert for manufacturing operations, translating regulatory, network and site requirements into shop-floor controls, risk assessments, training and continuous improvement. It provides technical leadership for contamination control, aseptic practices, Product Change Overs (PCOs), facility cleaning and disinfection, and coordinates work and coaching without formal people-management accountability.

Key responsibilities

• Lead contamination and cross-contamination FMEAs, operability studies, 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 projects
• Review routine and in-process metrics to spot leading indicators and emerging risks
• Assess aseptic techniques through Gemba observations, coach staff and close follow-up actions
• Partner with QC on microbial and environmental monitoring data, and with Manufacturing, Quality, Engineering, Facilities and Validation teams
• Turn regulations and standards into site procedures, controls and training, update SOPs and deliver process hygiene training
• Harmonize facility-cleaning, disinfection and environmental-monitoring procedures and job aids across all streams
• Maintain a strong shop-floor presence, support Tier communications and build cross-functional relationships

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
• Demonstrated ability to lead 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