Biologics Process Hygiene Lead - Contamination & Compliance

AbbVie; Singapore; On-site; SGD 180,000 - 280,000; Full time

Job summary

AbbVie is seeking a Process Hygiene Lead for Biologics Manufacturing to drive contamination control, aseptic practices and site readiness. You will translate regulatory requirements into practical shop-floor controls and lead cross-functional teams across manufacturing operations.

The role requires extensive experience in GMP environments, strong problem-solving and coaching skills, and the ability to influence without direct authority to ensure compliance and continuous improvement.

Qualifications

• Minimum 7 years of relevant experience in biologics/pharmaceutical manufacturing.
• 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.
• Strong technical writing, training, coaching, facilitation and stakeholder communications 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.

Responsibilities

• Lead contamination and cross-contamination FMEAs, PCOs, and risk assessments across Biologics manufacturing.
• Lead investigations into contamination events and environmental monitoring deficiencies; support CAPA and root-cause analysis.
• Drive process hygiene initiatives and continuous improvement, ensuring inspection readiness.
• Review microbial and environmental-monitoring data with QC; identify signals and support investigations.
• Collaborate with Manufacturing, Quality, Engineering, Facilities and Validation to address process hygiene risks.
• Translate regulations and standards into site procedures; develop SOPs and training; deliver process hygiene training.

Skills

Technical leadership

Data analysis

Training and coaching

Stakeholder communication

Gemba observations

Regulatory understanding

Education

Bachelor’s degree in Microbiology or related field

Job description

AbbVie is seeking a Process Hygiene Lead for Biologics Manufacturing to drive contamination control, aseptic practices and site readiness. You will translate regulatory requirements into practical shop-floor controls and lead cross-functional teams across manufacturing operations.

The role requires extensive experience in GMP environments, strong problem-solving and coaching skills, and the ability to influence without direct authority to ensure compliance and continuous improvement.