Biologics Process Hygiene Lead – Aseptic Excellence

AbbVie Inc.; Singapore; On-site; SGD 85,000 - 110,000; Full time

Job summary

AbbVie in Singapore seeks a seasoned Process Hygiene lead to oversee contamination control across Biologics manufacturing, including central services, cell culture and purification. You will translate regulatory requirements into practical shop-floor controls and drive improvements with guidance across QC, Manufacturing, Engineering and Validation.

The role demands hands-on expertise in aseptic techniques, FMEAs, CAPA and data-driven risk management, with a proven track record in GMP

Qualifications

• 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, aseptic processing, microbiology, quality or GMP-regulated environment.
• Experience with FMEAs, operability/risk assessments, data trending and shop-floor/Gemba assessments.
• Strong technical writing, training, coaching, facilitation and stakeholder communications skills.

Responsibilities

• Lead and execute contamination and cross-contamination FMEAs, operability studies, PCOs, change plans and process hygiene assessments across Biologics manufacturing operations.
• Lead investigations including contamination events, facility-cleaning and microbial control deficiencies; support root-cause analysis, CAPA, effectiveness checks and closure.
• Drive process hygiene initiatives and projects, including contamination risk-reduction, continuous-improvement and inspection-readiness activities.
• Translate applicable regulations and standards into site procedures, controls, training and practical shop-floor implementation plans.
• Build strong cross-functional relationships and influence stakeholders to achieve shared business goals.

Skills

cGMP

Aseptic techniques

Quality systems

Investigations

CAPA

Change control

SOP governance

FMEAs

Gemba

Statistical tools

Regulatory inspections

Education

Bachelor’s degree in Microbiology/ Biology/ Biotechnology/ Chemical Engineering/ Pharmacy

Job description

AbbVie in Singapore seeks a seasoned Process Hygiene lead to oversee contamination control across Biologics manufacturing, including central services, cell culture and purification. You will translate regulatory requirements into practical shop-floor controls and drive improvements with guidance across QC, Manufacturing, Engineering and Validation.

The role demands hands-on expertise in aseptic techniques, FMEAs, CAPA and data-driven risk management, with a proven track record in GMP