Process Hygiene Manager

AbbVie Pte Ltd; Singapore; Presencial; SGD 180 000 - 280 000; Tempo integral

Resumo da oferta

AbbVie is seeking a Senior Process Hygiene leader to govern site-wide hygiene programs, ensuring cGMP compliance, contamination control, and continuous improvement across Biologics Manufacturing streams.

You will align with global standards, lead risk assessments, and drive inspections readiness while developing the team and cross-functional partnerships.

Qualificações

• Bachelor’s degree required with 10+ years in biologics/pharma manufacturing.
• Experience leading process hygiene, contamination control and regulatory inspections.
• Strong leadership and cross-functional collaboration across sites and networks.
• Knowledge of environmental monitoring, microbiology and quality systems.

Responsabilidades

• Develop and maintain the site Process Hygiene strategy and governance.
• Represent the site to global Process Hygiene organization and drive adherence to standards.
• Oversight of cleaning, disinfection, contamination-control plans and risk assessments.
• Lead investigations, CAPA, and regulatory-inspection readiness activities.

Conhecimentos

Leadership

Governance

cGMP

Aseptic

FMEAs

Regulatory

Cross-functional

Data analysis

Formação académica

Bachelor’s degree in Microbiology/Biotech/Chemical Engineering

Descrição da oferta de emprego

Company Description

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

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 escalation 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.

Qualifications

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.

Additional Information

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.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html