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.