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Lead Engineer, Global Technical Operations Job

Date: Nov 15, 2017

Location: Singapore, SG

Company: MSD

Requisition ID: CHE004717

The GTO Lead introduces new products to the site, providing technical expertise on the manufacture of all drug products on site and transferring drug products to other facilities. In collaboration with supporting functional groups, the GTO Lead provides technical guidance on deviations, investigations and customer complaints. The GTO Lead leads continuous process improvement activities to enhance site performance metrics and contributes to global technical networks to share site experiences and expand on personal and site expertise.
  • Leads new product introductions to the site by assisting with process and equipment comparisons, new raw material introduction, development studies, cleaning processes development and validation, process fit and gap analysis.
  • Supports filing activities by leading process qualification activities, equipment qualification and cleaning validation. Expected to have the expertise knowledge of QMS chapter 13, 17 and 25 and 35 (sterile) and understands the principles of Quality by Design (QbD) and executes the requirements in support of a QbD filing 
  • Supports routine supply manufacture by providing on going technical support to the IPT and proactively monitoring the performance of equipment/module(s) or unit operation(s) during manufacturing and cleaning. Responds to shifts and trends in performance appropriately and based on the data identifies opportunities for improvement. 
  • The GTO Lead is the change owner for process Global Change Management (GCM) change controls. 
  • Leads and mentors in developing continuous process verification (CPV) plans and contributes and reviews to the CPV reports and annual product reviews. Conversant and able to coach in statistical analysis. 
  • Provides and coaches/mentors the GTO Engineers/Chemists in technical expertise related to equipment and manufacturing/cleaning processes in response to deviations and atypical events to understand and eliminate the root cause(s).
  • Leads investigations for non-emergency product complaints and deviations using problem solving tools such as KT. Ishikawa, FMEA, 5 Whys. Coaches the GTO Engineer/Chemist in problem solving skills.
  • Leads collaboration and sharing of best practices with internal/external SMEs (e.g. CPDC, PCT, Sterile council, ADC, CMSE and other groups within the GSTC network.
  • Complies with all divisional and site-specific policies, guidelines and procedures. Making safety adherence as a pre-requisite to employment.
  • Demonstrates and promotes safety, health & environment (SHE) leadership behaviour, ensuring that all activities are carried out in accordance with SHE requirements. Actively participates in GEMBA safety walk, HazOp. Speak on process safety and lead by example GTO safety commitments.
  • Where applicable, develops and reviews SOPs, gap analysis and Job Aids for GTO Subsystems in compliance with divisional and corporate policies and guidelines
  • Demonstrate leadership behavior in alignment with MSD leadership standards (Individual Contributor)
  • Practice Inclusion as the How and MSD Production Systems (MPS)
  • Leads personal career development with manager assistance through annual Performance Management Process (PMP), Employee Development Plan (EDP) and career mapping.
  • Any other duties as assigned by the Supervisor.
Qualifications

  • Bachelors,
    Masters or Ph.D. degree in a technical field, including Chemical or Mechanical
    Engineering, Chemistry or Pharmaceutical Sciences

  • Minimum
    4 years technical experience in pharmaceutical manufacturing industry

  • Expert knowledge of core
    technology/unit operations relevant to active pharmaceutical ingredient,
    Biotech and/or Non-Sterile manufacturing 



Job: Chemical Engineering
Other Locations:
Employee Status: Regular
Travel: No
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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