Process Engineer (WDA)

Merck Gruppe - MSD Sharp & Dohme; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company based in Singapore is seeking a PTO Process Engineer to provide technical supply support for drug product commercialization. The successful candidate will support new product introductions, conduct technical writing, and ensure compliance during the manufacturing process. Candidates with a technical degree are encouraged to apply, including fresh graduates. This role offers an opportunity to enhance technical expertise while contributing to continuous process improvements.

Qualifications

• Pharmaceutical experience preferred, fresh graduates are encouraged to apply.

Responsibilities

• Support new product introductions by conducting process comparisons and training technicians.
• Author associated documentation related to new product introduction.
• Provide technical support for compliance activities and regulatory submissions.

Skills

Technical writing

Process improvement

Validation and qualification processes

Education

Bachelor's, Master's or Ph.D. in a technical field

Job description

Job Description

JOB PURPOSE

The PTO Process Engineer provides technical supply support on the commercialization and manufacture of all drug products with minimal support from seniors or direct supervisor. He/ she supports all technical/ process activities, such as investigations, validation and qualification processes, risk assessments and process safety management activities under his/ her responsibilities.

The PTO Process Engineer also supports continuous process improvement activities to enhance site performance metrics and contributes to the global technical network to share site experiences/ knowledge and continuously expands on personal expertise. He/ she also supports the introduction of new products to the site and the transfer of drug products to other facilities.

MAIN RESPONSIBILITIES

• Supports new product introductions to the site by supporting and/or conducting process and equipment comparisons, new raw material introduction, development studies, clinical supplies manufacturing, cleaning processes development/ validation and training of technicians as required.
• Authors PPQ protocols, reports and other associated documentation related to a new product introduction.
• Demonstrates ability in technical writing for investigations, change request, PPQ reports and CMC sections.
• Is involved in/ supports the design and execution of small/ full scale experiments using appropriate methodology and/or simulations for products/ processes to evaluate the impact of proposed changes to validated equipment/ processes.
• Supports site and divisional capital projects and new facility start-up activities if applicable.
• Provides technical support related to the product, equipment and manufacturing/cleaning processes in response to deviations/ product complaints/ adverse events to identify point of occurrence, root cause and corrective/ preventative actions.
• Provides technical support for compliance activities such as audit and regulatory support.
• Demonstrates an understanding of the manufacturing lifecycle of a product including technical requirements, analytical regulatory guidelines/ expectations associated with global regulatory submissions.

QUALIFICATIONS

• Bachelors, Masters or Ph.D. degree in a technical field, including Chemical or Mechanical Engineering, Chemistry, Biological sciences or Pharmaceutical Sciences.
• Pharmaceutical experience preferred, fresh graduates are encouraged to apply.

Merck & Co., Inc. is an equal employment opportunity employer.