Process Hygiene Manager, Biologics Manufacturing

AbbVie; Singapore; On-site; SGD 180,000 - 260,000; Full time

Job summary

AbbVie Inc. seeks a Process Hygiene Manager for Biologics Manufacturing in Singapore. You will lead the site-wide program, govern contamination-control standards, and align with global network guidance to reduce risk and drive continuous improvement.

The role requires 10+ years in biologics/pharmaceutical manufacturing, strong leadership, and deep regulatory knowledge to support aseptic processing and quality systems. This position emphasizes cross-functional collaboration and site governance.

Qualifications

• 10+ years of biologics/pharmaceutical manufacturing experience.
• Strong leadership and cross-functional program governance.
• Deep knowledge of cGMP, contamination control, aseptic processing and quality systems.
• Experience with FMEAs, risk studies and regulatory/network standards.
• Ability to communicate complex technical info to senior leadership.

Responsibilities

• Develop and govern site Process Hygiene strategy, governance, priorities and roadmap.
• Lead cross-functional initiatives and ensure alignment with global standards.
• Oversee contamination-control programs, investigations and CAPA.
• Represent Process Hygiene during regulatory inspections and audits.

Skills

People leadership

Strategic planning

Program governance

Cross-functional leadership

Regulatory inspection knowledge

cGMP knowledge

Aseptic processing

Quality systems

CAPA

Risk assessment

Education

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

Job description

Process Hygiene Manager, Biologics Manufacturing

• Full-time
• Workday Global Grade: 17

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

Purpose

Provide site-wide leadership and governance for the Process Hygiene program across Biologics Manufacturing, covering Central Services, Cell Culture and Purification. Ensure manufacturing practices, contamination-control systems and process hygiene standards comply with applicable cGMP and regulatory requirements and align with network best practices, while driving sustained risk reduction and continuous improvement. The role also provides governance and strategic oversight of biologics facility cleaning and disinfection, and the integration of microbial and environmental monitoring insights into the site contamination-control program.

Major Responsibilities

Program Strategy, Governance and Network Alignment

• Develop and maintain the site Process Hygiene strategy, governance model, priorities and roadmap across all manufacturing streams.
• Serve as the site representative and primary conduit to the global/network Process Hygiene organization; lead alignment, adoption and reporting of network standards, regulatory expectations and best practices.
• Own site-level reporting and management review of process hygiene performance, including leading indicators, trends, operability studies, standards adherence, contamination-control priorities, investigations, projects and audit readiness.
• Establish andmaintaingovernance forbiologicsfacility cleaning and disinfection across biologics manufacturing, including standards, frequency, performance review and alignment across Central Services, Cell Culture and Purification.
• Ensure relevant microbial and environmental-monitoringdata,organism identification,excursionsand adverse trends are routinely reviewed and incorporated into contamination-control priorities, riskassessmentsand management reporting.

Technical and Compliance Leadership

• Provide overall governance for contamination and cross-contamination FMEAs, operability studies, aseptic-technique best practices, PCOs, change plans and other process hygiene risk assessments.
• Ensure timely interpretation and adoption of applicable regulations and network requirements; sponsor updates to procedures, training and controls.
• Provide senior subject matter expertise for complex contamination, bioburden, sterility, environmental-monitoring and process-hygiene investigations, including root-cause, CAPA and systemic-risk assessment.
• Establish a consistent Gemba and shop-floor engagement framework, ensuring actions are risk-based, assigned, tracked and effectively closed.
• Provide technical oversight for cleaning and disinfection strategy of biomanufacturing facility, including lifecycle maintenance of supporting procedures and controls.
• Represent Process Hygiene during regulatory inspections, internal audits and site governance forums, ensuring clear communication of strategy, performance, risks and remediation.

People and Culture

• Lead cross-functional process hygiene initiatives and capital or improvement projects; set priorities, remove barriers and upscale material risks.
• Lead, coach and develop the Process Hygiene team; build technical capability, succession and a high-performance, quality-focused culture.
• Build strong cross-functional relationships and influence stakeholders to achieve shared business goals.

Education

• Bachelor’s degree in Microbiology, Biology, Biotechnology, Chemical Engineering, Pharmacy, or a related scientific/ engineering discipline, with 10+ years of related experience required.

Essential Skills, Experience, and Competencies (includes Licenses, Credentials)

• Minimum 10 years of relevant experience in biologics/pharmaceutical manufacturing, aseptic processing, microbiology, quality or a related GMP-regulated environment required.
• Demonstrated people leadership, strategic planning, program governance and cross-functional project leadership required.
• Strong knowledge of cGMP, contamination control, aseptic processing, quality systems, investigations, CAPA, change control and regulatory inspection expectations required.
• Experience leading FMEAs, operability or risk studies, data trending and implementation of regulatory or network standards required.
• Ability to interpret complex technical and compliance information, make risk-based decisions with limited oversight and communicate effectively to senior leadership required.
• Strong stakeholder-management, influencing, conflict-resolution and technical-communication skills across site and global teams required.
• Working knowledge of statistical tools and environmental/process-monitoring data analysis preferred.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.