Process Hygiene Lead - Biologics Manufacturing

Job Description

Purpose:

Lead and execute Process Hygiene activities across Biologics Manufacturing, covering Central Services, Cell Culture and Purification. Serve as the Process Hygiene subject matter expert for Manufacturing operations, who translates regulatory, network and site requirements into practical shop-floor controls, risks assessments, training and continuous improvement initiatives. Provide technical leadership for contamination control, aseptic practices, Product Change Overs (PCOs), facility cleaning and disinfection. Provides technical leadership, work coordination, coaching and subject matter guidance without formal people-management accountability.

Major Responsibilities:

Technical Execution and Risk Management 

• Lead and execute contamination and cross-contamination FMEAs, operability studies, Product Change Overs (PCOs), change plans and process hygiene assessments across Biologics manufacturing operations. 
• Lead and provide subject matter expertise for process-hygiene related investigations including contamination events, facility-cleaning and microbial control deficiencies; support root-cause analysis, CAPA, effectiveness checks and timely closure. 
• Drive process hygiene initiatives and projects, including contamination risk-reduction, continuous-improvement and inspection-readiness activities. 
• Perform data review of routine and in-process metrics to identify leading indicators, emerging risks and improvement opportunities. 
• Assess aseptic techniques and operating practices through Gemba and floor observations; provide coaching and drive follow-up actions to closure. 
• Partner with QC to review relevant microbial and environmental-monitoring data, identify emerging signals and support investigation of excursions or atypical findings and trends. 
• Collaborate with Manufacturing, Quality, Engineering, Facilities and Validation teams to address process hygiene risks and provide SME input to facility, equipment, utility and capital-project decisions. 

Training and Alignment 

• Translate applicable regulations, network standards and best practices into site procedures, controls, training and practical implementation plans. 
• Drive SOP updates and aseptic-technique best-practices adherence; develop and deliver process hygiene training and coaching for manufacturing personnel. 
• Build consistent process hygiene practices across Biologics Manufacturing operations for all streams, while recognizing justified process-specific differences. 
• Translate facility-cleaning, disinfection and environmental-monitoring requirements into harmonized procedures, job aids, training and practical shop-floor controls across all manufacturing streams. 
• Maintain strong shop-floor presence and support Tier communications; clearly communicate trends, risks, actions and progress to stakeholders. 

People and Culture

• Build strong cross-functional relationships and influence stakeholders to achieve shared business goals.
• Sets positive team environment and amplifies the AbbVie Ways We Work behaviors.

Qualifications

Education

• Bachelor’s degree in Microbiology, Biology, Biotechnology, Chemical Engineering, Pharmacy, or a related scientific/engineering discipline required. 

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

• Minimum 7 years of relevant experience in biologics/ pharmaceutical manufacturing, aseptic processing, microbiology, quality or a related GMP-regulated environment required. 

• Hands-on knowledge of cGMP, contamination control, aseptic techniques, quality systems, investigations, CAPA, change control and SOP governance required. 

• Experience conducting FMEAs, operability/ risk assessments, data trending and shop-floor/ Gemba assessments required. 

• Demonstrated ability to lead technical initiatives and cross-functional teams without direct authority required. 

• Strong technical writing, training, coaching, facilitation and stakeholder-communication skills required. 

• Ability to analyze complex issues, apply risk-based judgment and recommend practical, compliant solutions with limited oversight required. 

• Experience supporting regulatory inspections or internal audits preferred. 

• Working knowledge of basic 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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