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GSK

Develops medicines, vaccines, and consumer health

MSAT Engineer Product Specialist Trainee

Bioprocess & BiomanufacturingConfirmed live in the last 24 hours
Full-timeSingaporeNo salary listed

About the Job

Requirements

  • A Bachelor's degree in Chemical Engineering, Biochemical or Bioprocess Engineering, Biotechnology, Pharmaceutical Science, Life Science, or a related engineering or science discipline.
  • Understanding of databases and SQL.
  • Strong background in Microsoft Office, including Excel, Word, Project, PowerPoint, and Visio.
  • Troubleshooting capabilities and the ability to apply engineering thinking and principles to complex technical and process issues with support from the Product Owner Expert.
  • Written and verbal communication skills.
  • Quantitative and qualitative analytical skills.
  • Understanding of Life Cycle Management disciplines, cross-functional skills, and processes.
  • Experience with process monitoring and statistical data analysis using statistical software such as RedStar, Spotfire, JMP, MiniTab, or Discoverant.
  • Experience managing projects of medium complexity and medium-sized, multi-workstream projects.
  • Knowledge of GSK vaccine processes and procedures, the vaccine environment, regulatory requirements, NRA release, and the specificities of each vaccine family.
  • Knowledge of the GMP environment, biopharmaceutical production processes, and cGMP regulations and guidelines.
  • Applicants must be Singapore Citizens or Permanent Residents.

Responsibilities

  • Provide technical support to the commercial manufacturing team, including change assessment, process monitoring, troubleshooting, and continuous improvement.
  • Contribute to the lifecycle of products and processes manufactured at GSK Tuas, from inception through engineering design and manufacture to service and disposal of manufactured products.
  • Participate in the Continued Process Verification cycle for the designated product.
  • Assist the Product Owner in managing CPV meetings.
  • Apply KPIs to support meaningful CPP/CQA trending and reporting of key process data, and to identify changing quality trends and issues.
  • Review and analyze process trends and identify changing quality trends and issues.
  • With support from the Product Owner, suggest corrective actions to resolve issues and improve manufacturing-process robustness and consistency.
  • Maintain the TRA, PCS, DTP, CQA, and QTTP for the designated product.
  • Compile, interpret, and organize process and product data for periodic reviews, audits, and regulatory support.
  • Work with MSAT Engineers, Manufacturing Engineers, and Manufacturing to monitor process performance using real-time performance data.
  • Collect, record, and produce reports on metrics.
  • Establish visual tracking and other tools to improve audit readiness and trend analysis.
  • Read and interpret statistical diagrams, drawings, and other schematics, and monitor processes for performance and problem indicators.
  • Update the product's process history file throughout its lifecycle.
  • Assess the impact of changes on the current validated process status and identify revalidation or reevaluation activities needed.
  • Work with MSAT and MSAT Process teams to identify and confirm critical process parameters needed for equipment and process validation.
  • Support audit preparation and management by participating in L2 audits, corporate and regulatory inspections, and responding to inspectors' questions.
  • Contribute to projects related to product lifecycle changes or optimization.
  • Participate in product investigation task forces or working groups.

Desired Qualifications

  • Strong project management, planning, and organizational skills.

About the Company

GSK

Develops medicines, vaccines, and consumer health

GSK is a global healthcare company focused on three main areas: Pharmaceuticals, Vaccines, and Consumer Healthcare. It develops medicines, vaccines, and consumer health products to improve health outcomes worldwide. Its products address diseases in respiratory, HIV, oncology, and immuno-inflammatory areas; vaccines for influenza, shingles, and COVID-19; and over-the-counter wellness products. The company relies on substantial R&D and strategic partnerships to bring new products to market and to address health needs. Revenues come from sales of medicines, vaccines, and consumer health items, often complemented by patient support programs and collaborations with governments and biotech partners.

Company size
10,001+
Company stage
IPO
Headquarters
London, United Kingdom
Founded
1891

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