Senior Pharmaceutical Operations Engineer

1 week ago


Singapur, Singapore Thermo Fisher Scientific Full time
Job Description

We are seeking a highly motivated and experienced Senior Pharmaceutical Operations Engineer to join our team at Thermo Fisher Scientific.

Key Responsibilities
  • Support the development and implementation of new pharmaceutical products and processes, including NPI and qualification activities.
  • Collaborate with production managers to optimize yields, improve plant flexibility, and minimize costs while adhering to GMP, budget, and safety standards.
  • Lead significant quality investigations and act as a technical reviewer for change controls.
  • Provide technical expertise for day-to-day production activities, including root cause analysis, process improvements, and implementation of new technologies.
  • Support quality compliance activities, including documentation updates, change control, investigations, and CAPA.
  • Supervise and review CPV and APR activities to monitor and adjust process parameters and equipment performance.
  • Ensure continuous improvement in production structure by proposing actions related to plant layout, GMP adaptation, and cost optimization.
  • Participate in critical technical projects related to commercial sterile pharmaceuticals' production.
  • Serve as the main interface on technical issues between technical operations and customers.
  • Ensure robust and efficient transfer of new products/processes into production.
  • Participate in project meetings to transpose customer production processes and support the production process improvements.
  • Promote EHS safe practices and ensure safety adherence to standards and SOPs.
Requirements
  • Minimum 2 to 5 years of pharmaceutical experience
  • Knowledge of pharmaceutical manufacturing processes and GMP
  • Experience in statistical process controls and related tools
  • Good digital literacy
  • Knowledge of safety and environmental regulations
  • Flexibility and leadership skills
  • Positive relationship skills and attention to detail
  • Experience in sterile injectable drug production and packaging/visual inspection preferred
  • Highly motivated to work in the pharmaceutical industry
  • Ability to work as part of a team


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