Process Hygiene Lead

AbbVie Inc.; Singapore; On-site; SGD 180,000 - 300,000; Full time

Job summary

AbbVie Inc. is seeking a senior Process Hygiene Lead for Biologics Manufacturing in Singapore. You will translate regulatory and site requirements into shop-floor controls and drive aseptic practices, facility cleaning and disinfection, while providing SME guidance across manufacturing operations.

You will lead investigations, CAPA and risk assessments, coordinate with QC, Engineering and Facilities, and mentor teams to ensure inspection readiness and continuous improvement across all streams.

Qualifications

• Bachelor’s degree in Microbiology, Biology, Biotechnology, Chemical Engineering, Pharmacy or related field.
• Minimum 7 years in biologics/pharmaceutical manufacturing or GMP environment.
• Experience with contamination control, aseptic processing and investigations.

Responsibilities

• Lead contamination control and cross-contamination FMEAs and changeovers.
• Coordinate investigations, CAPA, and root-cause analyses for hygiene issues.
• Drive process-hygiene initiatives and continuous-improvement projects.
• Review microbial and environmental monitoring data to identify risks.
• Coach and align cross-functional teams on aseptic practices and SOPs.

Skills

cGMP compliance

Aseptic techniques

Contamination control

FMEAs

Root-cause analysis

Data trending

Education

Bachelor’s degree in Microbiology or related

Tools

CAPA tracking

Quality systems

Job description

Company Description

About AbbVie

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 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