Process Hygiene Lead

AbbVie; Singapore; On-site; SGD 180,000 - 280,000; Full time

Job summary

AbbVie is seeking a Process Hygiene Lead for Biologics Manufacturing to drive contamination control, aseptic practices and site readiness. You will translate regulatory requirements into practical shop-floor controls and lead cross-functional teams across manufacturing operations.

The role requires extensive experience in GMP environments, strong problem-solving and coaching skills, and the ability to influence without direct authority to ensure compliance and continuous improvement.

Qualifications

• Minimum 7 years of relevant experience in biologics/pharmaceutical manufacturing.
• Hands-on knowledge of cGMP, contamination control, aseptic techniques, quality systems, investigations, CAPA, change control and SOP governance.
• Experience conducting FMEAs, operability/risk assessments, data trending and shop-floor/Gemba assessments.
• Strong technical writing, training, coaching, facilitation and stakeholder communications skills.
• Ability to analyze complex issues, apply risk-based judgment and recommend practical, compliant solutions with limited oversight.
• Experience supporting regulatory inspections or internal audits preferred.

Responsibilities

• Lead contamination and cross-contamination FMEAs, PCOs, and risk assessments across Biologics manufacturing.
• Lead investigations into contamination events and environmental monitoring deficiencies; support CAPA and root-cause analysis.
• Drive process hygiene initiatives and continuous improvement, ensuring inspection readiness.
• Review microbial and environmental-monitoring data with QC; identify signals and support investigations.
• Collaborate with Manufacturing, Quality, Engineering, Facilities and Validation to address process hygiene risks.
• Translate regulations and standards into site procedures; develop SOPs and training; deliver process hygiene training.

Skills

Technical leadership

Data analysis

Training and coaching

Stakeholder communication

Gemba observations

Regulatory understanding

Education

Bachelor’s degree in Microbiology or related field

Job description

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 at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

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,trainingand continuous improvement initiatives. Provide technical leadership for contamination control, aseptic practices, Product Change Overs (PCOs), facility cleaning and disinfection.Provides technical leadership, work coordination,coachingand 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 matterexpertisefor process-hygiene related investigations including contamination events, facility-cleaning and microbial control deficiencies; support root-cause analysis, CAPA, effectiveness checks andtimelyclosure.
• Drive process hygiene initiatives and projects, including contamination risk-reduction,continuous-improvementand inspection-readiness activities.
• Perform data review of routine and in-process metrics toidentifyleading indicators, emergingrisksand 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, identifyemerging 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,utilityand capital-project decisions.

Training and Alignment

• Translate applicable regulations, network standards and best practices into site procedures, controls,trainingand 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,trainingand practical shop-floor controls across all manufacturing streams.
• Maintain strong shop-floor presence and support Tier communications; clearly communicate trends, risks,actionsand 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, ora relatedscientific/engineering disciplinerequired.

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

• Minimum 7 years of relevant experience in biologics/ pharmaceutical manufacturing, aseptic processing, microbiology,qualityor a related GMP-regulated environmentrequired.
• Hands-on knowledge of cGMP, contamination control, aseptic techniques, quality systems, investigations, CAPA, changecontroland SOP governancerequired.
• Experience conducting FMEAs, operability/ risk assessments, data trending andshop-floor/ Gemba assessmentsrequired.
• Demonstrated ability to lead technical initiatives and cross-functional teams without direct authority required.
• Strong technical writing, training, coaching,facilitationandstakeholder-communicationskillsrequired.
• Ability to analyze complex issues, apply risk-basedjudgmentand recommend practical, compliant solutions with limited oversightrequired.
• Experience supporting regulatory inspections or internal audits preferred.
• Working knowledge of basic statistical tools and environmental/ process-monitoring data analysispreferred.

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 applicants seeking a reasonable accommodation.