Process Hygiene Manager

• 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.

• 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.

• 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

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

• 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, visit https://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