The Senior GTO Engineer either independently or with minimal support introduces new products to the site, provides technical expertise on the manufacture of assigned drug products on site and transfers drug products to other facilities. In collaboration with supporting functional groups, the Senior GTO Engineer provides technical guidance on deviations, investigations and customer complaints. The Sr. GTO Engineer develops and leads/participates in continuous process improvement activities to enhance site performance metrics. Participation in product development teams (IDST) and global technical networks to share site experiences and expand on personal and site expertise is required.
- Leads simple new product introductions to the site by conducting process and equipment comparisons, new raw material introduction, development studies and clinical supplies manufacturing, cleaning processes development and validation and training of technicians as required.
- Designs and executes small/full-scale experiments using design of experiments methodology and/or simulations for new products to evaluate the impact of proposed changes to validated equipment/processes.
- Supports filing activities by developing and leading process qualification activities for equipment, process and material changes.
- 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 and reviews IPT metrics to identify and implement opportunities for improvement utilizing the lean six sigma tools.
- Proactively monitors the performance of equipment/module(s) or unit operation(s) during manufacturing and cleaning through the use of control charts. Performs statistical analysis of the data and responds to shifts and trends in performance appropriately by engaging various functional areas. The Sr. GTO Engineer is the change owner for process Global Change Management (GCM) change controls.
- Develops continuous process verification (CPV) plans, analyses the data and authors the CPV reports and annual product reviews. Conducts periodic cleaning assessments as part of continuous process improvement.
- Executes complex equipment/process/automation changes as required for process improvements, including changes to process/cleaning batch sheets.
- Provides technical expertise related to equipment and manufacturing/cleaning processes in response to deviations to understand and eliminate the root cause(s).
- Leads investigations for emergency product complaints, investigations and deviations.
- Provides technical guidance in supports of site and divisional capital projects and new facility start-up activities, including full-scale process demonstration, process validation, and cleaning validation
- Actively participates and shows commitment to collaborations by sharing of best practices with internal/external subject matter experts (SMEs).
- Mentors and coaches Engineers/interns to develop future scientific talent
- Develop and update GTO training packages, including new product and new product/process specific training (PST)
- Demonstrates and promotes safety, health & environment (SHE) leadership behavior, ensuring that all activities are carried out in accordance with SHE requirements
- Where applicable, develops SOPs and Job Aids for GTO Subsystems in compliance with divisional and corporate policies and guidelines
- Continuously improves, simplifies, and optimizes procedures and systems
- Demonstrates leadership behavior in alignment with MSD leadership standards
- Embraces 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.
- Bachelors, Masters, or Ph.D degree in a technical field, including Chemical or Mechanical Engineering, Chemistry or Pharmaceutical Sciences
- Minimum 2 years technical experience in pharmaceutical manufacturing industry
Job: Process Engineering Job Title:Spclst, Engineering
Primary Location: APAC-SG-Singapore-Singapore
Employee Status: Regular
Number of Openings: 1
Company Trade Name:MSD
Job Segment: Manufacturing Engineer, Engineer, Product Development, Pharmaceutical, Engineering, Research, Science, Customer Service
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