MSD Process Engineer Adv PCP - Years Contract 

Singapore, Singapore 

293782460

Job Description

• Develop strategies that alignwith business imperatives
• Based in Singapore, the regional hub forAsia Pacific (AP)andtop-ranked biopharmaceutical company on the Straits TimesandStatista’s list of Best Employers in Singapore for three consecutive years (2021, 2022, 2023).
• Join thepremier biopharmaceutical companythat has beenin Singapore for more than 25 years and in AP for over 60 years.

Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

WHAT YOU WILL DO

The Process 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 Process Engineer provides technical guidance on deviations, investigations and customer complaints. The Process Engineer also develops and leads/participates in continuous process improvement activities to enhance site performance metrics.

• 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. Engineer, PTO 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
• Demonstrates and promotes safety, health & environment (SHE) leadership behavior, ensuring that all activities are carried out in accordance with SHE requirements
• Any other duties as assigned by the Supervisor.

WHAT YOU MUST HAVE

To be successful in this role, you will have:

• Bachelor or Masters Degree in a technical field, including Chemical/ Mechanical Engineering, or Pharmaceutical Sciences
• 0 to 3 years of technical experience in manufacturing industry preferred.
• Knowledge of problem-solving tools (such as fishbone analysis, 5 WHY, logic fault tree etc.) and troubleshooting skills
• Knowledge of data analysis (familiarity with use of statistical software such as Minitab or JMP is preferred)
• Good verbal communication skill and technical writing skill
• Attention to detail

This is an

• •Singaporeans/SingaporePRs only
  • Fresh graduates with relevant internship are welcome to apply
  •PMETs/Mid-Careeristwith no prior work experience in Biopharma industry are welcome to apply
  

WHAT YOU CAN EXPECT

• Limitless opportunities across various areas in Manufacturing; well-structured career path
• A state-of-the-art facility that delivers solution to its customers world-wide
• Highly engaging team that aims to innovate the future

Current Contingent Workers apply

Intern/Co-op (Fixed Term)

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