Biologics Process Hygiene Lead

AbbVie Pte Ltd; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

AbbVie in Singapore seeks a senior Process Hygiene Lead for Biologics Manufacturing. You will own contamination control and risk assessments across Cell Culture, Purification and Central Services to ensure GMP compliance.

Provide SME guidance on aseptic practices, investigations, CAPA and facility cleaning; coordinate with Manufacturing, Quality, Engineering and Validation to maintain inspection readiness.

Qualifications

• Minimum 7 years of relevant experience in biologics/pharmaceutical manufacturing, aseptic processing, microbiology, quality or GMP environments.
• Hands-on knowledge of cGMP, contamination control, aseptic techniques, quality systems, investigations, CAPA, change control and SOP governance.

Responsibilities

• Lead and execute contamination and cross-contamination FMEAs, operability studies, PCOs, change plans and process hygiene assessments across Biologics manufacturing operations.
• Investigate contamination events and facility-cleaning deficiencies; support root-cause analysis, CAPA, effectiveness checks and timely closure.
• Drive process hygiene initiatives and projects, including contamination risk-reduction, continuous improvement and inspection-readiness activities.
• Perform data review of routine and in-process metrics to identify leading indicators, emerging risks and improvement opportunities.
• Assess aseptic techniques and operating practices through Gemba and floor observations; provide coaching and drive follow-up actions to closure.
• Partner with QC to review relevant microbial and environmental-monitoring data, identify emerging signals and support investigation of excursions or atypical findings and trends.
• Collaborate with Manufacturing, Quality, Engineering, Facilities and Validation teams to address process hygiene risks and provide SME input to facility, equipment, utility and capital-project decisions.
• Translate applicable regulations, network standards and best practices into site procedures, controls, training and practical implementation plans.
• Drive SOP updates and aseptic-technique best-practices adherence; develop and deliver process hygiene training and coaching for manufacturing personnel.
• Build consistent process hygiene practices across Biologics Manufacturing operations for all streams, while recognizing justified process-specific differences.
• Translate facility-cleaning, disinfection and environmental-monitoring requirements into harmonized procedures, job aids, training and practical shop-floor controls across all manufacturing streams.
• Maintain strong shop-floor presence and support Tier communications; clearly communicate trends, risks, actions and progress to stakeholders.

Skills

FMEA

Operability assessment

Aseptic techniques

Environmental monitoring

Root cause analysis

Data trend analysis

Cross-functional collaboration

Technical writing

Education

Bachelor’s degree in Microbiology, Biology, Biotechnology, Chemical Engineering, Pharmacy or related discipline

Tools

Statistical tools

Environmental monitoring systems

Job description

AbbVie in Singapore seeks a senior Process Hygiene Lead for Biologics Manufacturing. You will own contamination control and risk assessments across Cell Culture, Purification and Central Services to ensure GMP compliance.

Provide SME guidance on aseptic practices, investigations, CAPA and facility cleaning; coordinate with Manufacturing, Quality, Engineering and Validation to maintain inspection readiness.