Process Hygiene Lead, Biologics Manufacturing

AbbVie Pte Ltd; Singapore; Presencial; SGD 150 000 - 190 000; Tempo integral

Resumo da oferta

AbbVie Singapore seeks an experienced Process Hygiene Lead to oversee contamination control, aseptic practices and change-overs across Biologics manufacturing. You will translate regulatory and network requirements into practical shop-floor controls and drive improvements.

Responsibilities include leading FMEAs, investigations, CAPA, training and cross-functional collaboration to ensure inspection readiness and robust process hygiene across all streams.

Qualificações

• Bachelor’s degree in Microbiology, Biology, Biotechnology, Chemical Engineering, Pharmacy, or related scientific/engineering discipline required.
• Minimum 7 years of relevant experience in biologics/pharmaceutical manufacturing and GMP-regulated environments.
• 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.
• Demonstrated ability to lead technical initiatives and cross-functional teams without direct authority.
• Strong technical writing, training, coaching, facilitation and stakeholder-communication 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.
• Working knowledge of basic statistical tools and environmental/process-monitoring data analysis preferred.

Responsabilidades

• Lead contamination and cross-contamination FMEAs and change plans across Biologics manufacturing operations.
• Lead investigations for contamination events 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.
• 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.

Conhecimentos

GMP knowledge

Aseptic techniques

Quality systems

Investigations & CAPA

Change control

SOP governance

Cross-functional collaboration

Formação académica

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

Ferramentas

Statistical tools

Descrição da oferta de emprego

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

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,facilitationand stakeholder-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, visithttps://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