Process Hygiene Manager

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 and maintain governance for biologics facility 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-monitoring data organism identification excursions and adverse trends are routinely reviewed and incorporated into contamination-control priorities risk assessments and 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 escalate 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

• Bachelors 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. 

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Work :

No

Employment Type :

Full-time