Process Engineer

2 weeks ago

Singapore MSD Full time

THE OPPORTUNITY
-
Develop strategies that align with business imperatives
-
Based in Singapore, the regional hub for
Asia Pacific (AP) and
top-ranked biopharmaceutical company on the Straits Times and
Statista's list of Best Employers in Singapore for two consecutive years (2020, 2021)
:

  • Join the
    premier biopharmaceutical company that has been
    in 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.


Reporting to the Manager of Engineering, the Process Engineer/ Chemist provides technical supply support on the commercialization and manufacture of all drug products either independently or with mínimal support (seeking support/ escalating efficiently where needed).

They support/lead all technical/ process activities (for example) investigations, validation and qualification processes, risk assessments, process safety management activities under their responsibilities and could be responsible for technical product stewardship activities.

The Engineer/ Chemist also supports continuous process improvement activities to enhance site performance metrics and contributes to the global company technical network to share site experiences/ knowledge and continuously expands on personal expertise.

They are also supports/leads the introduction of new products to the site and the transfer of drug products to other facilities.


WHAT YOU WILL DO

  • 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. Proactively identify solutions with support from seniors or direct supervisor to address issues that arose during experiment/evaluation
  • Provides technical expertise 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. Where applicable, develops SOPs, gap analyses and procedures for Quality/EHS subsystems/ topics in compliance with regulatory requirements, divisional and corporate policies and guidelines.
  • Supports and manages product portfolio activities. Examples (but not limited to) include managing documentation updates (e.g.

SOPS, batchsheets, recipes), quality risk assessments, change control management/ filing support (if applicable) and validation activities such as equipment qualification, simple process validation and cleaning validation/monitoring activities.

Expected to have a working knowledge of respective compliance topics related to the above-mentioned activities and understands the principles of Quality by Design (QbD) and executes the requirements in support of a QbD filing where applicable.


  • Proactively monitors the performance of process parameters, critical quality attributes and equipment/module(s)/unit operation(s) performance during manufacturing and cleaning. This could involve leading/participating in Prospective Process Analysis (PPA), statistical analysis and response to shifts and trends in process performance. Where applicable (under the guidance of colleagues if necessary), undertakes responsibilities as an active site product steward and is a member of the Value Chain Technical Team.
  • In addition, participates in Continued Process Verification and Annual Product review activities as part of product lifecycle management. Applies moderately complex statistical and risk analysis tools to evaluate actions required to ensure product robustness across applicable manufacturing equipment and processes.
  • Demonstrates good understanding of product and sterile boundary of the current validated processes. Have good knowledge of the raw materials and PCC (product contact components) used for the products under his/her responsibility.

WHAT YOU MUST HAVE
To be successful in this role, you will have:

Qualification:

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

Experience:

Minimum 2 years technical experience preferably in manufacturing, oil and gas or semiconductor industries.

WHAT YOU CAN EXPECT

  • Limitless opportunities across various areas in Manufacturing; wellstructured career path
  • A stateoftheart facility that delivers solution to its customers worldwide
  • Highly engaging team that aims to innovate the future
Our Manufacturing & Supply Division is committed to be the most trusted supplier of b

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