Steven Lin

Head of MSAT @ Acepodia

About

Experienced Pharmaceutical Professional with Strong Technical Expertise Results-driven professional with 11 years of experience in pharmaceutical manufacturing, specializing in Production Operations, Project Management, Technical Services, and Quality System Compliance. Demonstrated expertise in Aseptic Operations, Oral Solid Dosage (OSD) processes, Site Validation events, and Facility Management. Proven ability to collaborate effectively across cross-functional departments, fostering a high-involvement culture that enhances employee engagement and drives operational excellence. Well-versed in pharmaceutical regulatory requirements, compliance analysis, and site self-audits. Extensive experience with FDA, EMA, and PMDA audits, with a strong track record of maintaining compliance and achieving no major findings during regulatory inspections. Adept at strengthening GMP compliance and enhancing operational quality culture in partnership with colleagues. Expertise includes: ■ GMP Compliance ■ Quality Risk Assessment ■ Quality System Compliance ■ Six Sigma Green Belt ■ Site Facility Management ■ Site Self Audit (SSA) ■ SME for Aseptic/PKG Equip. ■ Site Validation Management ■ Project Management

Country

City

Singapore

Industry

Pharmaceuticals

Skill

Manufacturing Operations Management, Capital project management, FDA GMP, Pharmaceutical Industry, Pharmaceutical Serialization, Pharmaceutical Packaging, Package strategie, Pharmaceutical Engineering

Experience

Head of MSAT

Acepodia

2024-7 - Present · 2 yrs 3 mos

Responsiable for overseeing the Cell and Gene Therapy Center of Excellence (CGTCoE) Site Facility of Acepodia to ensure smooth Facility Operations, Engineering Support, and Quality Compliance. Key responsibilities include managing the Site Validation Master Plan (SVMP) to uphold quality standards, overseeing the Calibration Program for equipment suitability, and conducting Quality Risk Management and Assessments to ensure regulatory compliance. Additionally, the position requires leading and supporting projects to enhance efficiency and achieve excellence in deliverables.

QSC & QV Manager

Acepodia

2023-2 - 2024-10 · 1 yr 9 mos

台灣新北市

Responsible for Quality System Compliance and Site Validation Master Plan management, Process optimization and validation for cell therapy aseptic product (ATMP), including design of the validation process, cleaning process validation, delivers training, review of test summary results/CPP/CQA and report preparation, and also response for Site Equipment Qualification event. Risk assessment to ensure compliance with current regulation including deviation investigation, CAPA and CAPA EV for technical process issues and support trouble shooting from Production.

Technical Service Senior Specialist

Pfizer

2019-10 - 2023-1 · 3 yrs 4 mos

PGS Hsinchu

Responsible for Site Validation Master Plan management, Process optimization and validation for aseptic product, including design of the validation process, cleaning process validation, delivers training, review of test summary results/CPP/CQA and report preparation, and also response for Equipment Qualification (Subject Matter expert (SME) of Depyrogenation Oven, Autoclave, Filling Line and Lyophilizer). Risk assessment to ensure compliance with current regulation, for example glove compatibility and sterilization grade filter assessment and for deviation investigation, CAPA and CAPA EV for technical process issues and support trouble shooting from Production. Internal Site Self Audit member and cooperate with internal audit to assess the level of compliance with PIC/S GMP, facility policies and procedures.

Maintenance & Engineering Advanced Specialist (Project Manager)

Alvogen

2018-3 - 2019-9 · 1 yr 7 mos

Nantou, Taiwan

Response for Region Capital Projects Management (Korea/ Taiwan/ Japan/ India). Project manager for Track and Trace system (Serialization system), including integration of packaging system with the serialization requirements Responsible for design of site packaging line optimization and project manager for New oncology Packaging Line. Design and implement clean room/ equipment for site production area and laboratory area.

Production Supervisor

Alvogen

2015-7 - 2018-3 · 2 yrs 9 mos

Taiwan

Manage and lead the packaging team (>20 staffs) to deliver over 50 SKU. Lead Production Deviation Investigator Team for deviation investigation and include the product complaint management. Maintain equipment/system at its highest Operational Equipment Efficiencies (OEE) with high reliability, minimum main time between repair or adjustment, reducing time for parts change etc. Introduce shop floor operating efficiencies, for example Kaizen initiatives and Gamba walk.