Process Engineer

1 month ago

Singapore Msd International Gmbh (singapore Branch) Full time

Process Engineer (WDA) - 2 Years Contract

  • 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.

WHAT YOU WILL DO

Responsibilities include, but are not limited to:

  • 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:

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

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

Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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