Contamination Control Lead, Biologics Manufacturing

AbbVie Pte Ltd; Singapore; Presencial; SGD 150 000 - 190 000; Tempo integral

Resumo da oferta

AbbVie Singapore seeks an experienced Process Hygiene Lead to oversee contamination control, aseptic practices and change-overs across Biologics manufacturing. You will translate regulatory and network requirements into practical shop-floor controls and drive improvements.

Responsibilities include leading FMEAs, investigations, CAPA, training and cross-functional collaboration to ensure inspection readiness and robust process hygiene across all streams.

Qualificações

• Bachelor’s degree in Microbiology, Biology, Biotechnology, Chemical Engineering, Pharmacy, or related scientific/engineering discipline required.
• Minimum 7 years of relevant experience in biologics/pharmaceutical manufacturing and GMP-regulated environments.
• Hands-on knowledge of cGMP, contamination control, aseptic techniques, quality systems, investigations, CAPA, change control and SOP governance.
• Experience conducting FMEAs, operability/risk assessments, data trending and shop-floor/Gemba assessments.
• Demonstrated ability to lead technical initiatives and cross-functional teams without direct authority.
• Strong technical writing, training, coaching, facilitation and stakeholder-communication skills.
• Ability to analyze complex issues, apply risk-based judgment and recommend practical, compliant solutions with limited oversight.
• Experience supporting regulatory inspections or internal audits preferred.
• Working knowledge of basic statistical tools and environmental/process-monitoring data analysis preferred.

Responsabilidades

• Lead contamination and cross-contamination FMEAs and change plans across Biologics manufacturing operations.
• Lead investigations for contamination events and microbial control 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.

Conhecimentos

GMP knowledge

Aseptic techniques

Quality systems

Investigations & CAPA

Change control

SOP governance

Cross-functional collaboration

Formação académica

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

Ferramentas

Statistical tools

Descrição da oferta de emprego

AbbVie Singapore seeks an experienced Process Hygiene Lead to oversee contamination control, aseptic practices and change-overs across Biologics manufacturing. You will translate regulatory and network requirements into practical shop-floor controls and drive improvements.

Responsibilities include leading FMEAs, investigations, CAPA, training and cross-functional collaboration to ensure inspection readiness and robust process hygiene across all streams.