Senior Process Engineer, Pharmaceutical Technical Operations

4 weeks ago

Singapore MSD Full time

Job Description

THE OPPORTUNITY

  • Develop strategies aligned with business goals
  • Based in Singapore, the regional hub for Asia Pacific (AP) and leading biopharmaceutical company on the Straits Times and Statista's list of Best Employers in Singapore for three consecutive years (2021, 2022)
  • Join the prominent biopharmaceutical company established in Singapore for over 25 years and in AP for more than 60 years.

Our Engineers play a vital role in keeping internal and external manufacturing operations smooth, driving continuous improvement and innovation. With a wide array of facilities and environments, our Engineers have diverse opportunities in areas such as Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.

WHAT YOU WILL DO

Job Purpose

The PTO Senior Process Engineer/ Chemist is responsible for providing technical support in the commercialization and manufacturing of all drug products either independently or with minimal assistance. They oversee all technical and process activities, including investigations, validation, risk assessments, and process safety management, and may also handle technical product stewardship tasks. Additionally, they lead continuous process improvement efforts to enhance site performance metrics and contribute to the global technical network by sharing site experiences and knowledge.

The PTO Senior Process Engineer/ Chemist supports the objectives set by their seniors/ direct supervisor.

Main Responsibilities

  • Supports or leads (with minimal guidance) the introduction of new products to the site, conducting process and equipment comparisons, new raw materials introduction, development studies, manufacturing of clinical supplies, cleaning process development/ validation, and technician training as needed.
  • Participates in/exercises the design and implementation of small/ full-scale experiments using appropriate methods to assess the impact of proposed changes to validated equipment/ processes.
  • Provides technical guidance for site and divisional capital projects and new facility start-up activities.
  • Offers technical expertise related to the product, equipment, and manufacturing/cleaning processes in response to deviations, product complaints, or adverse events to identify root causes and take corrective/ preventive actions.
  • Provides technical support for compliance activities such as audits and regulatory support.
  • Manages product portfolio activities, including documentation updates, quality risk assessments, change control management, and validation activities.
  • Supports routine supply manufacture by providing ongoing technical assistance to the IPT and identifying opportunities for improvement.
  • Monitors process parameters, quality attributes, and equipment performance during manufacturing and cleaning to ensure smooth operations.

Additionally, participates in Continued Process Verification and Annual Product review activities as part of product lifecycle management, applying statistical and risk analysis tools to ensure product robustness across applicable manufacturing equipment and processes.

  • Demonstrates good understanding of product CPP, CQA, Cpk, and sterile boundary of the current validated processes.
  • Actively engages in collaboration and best practice sharing across the global company S&T network.
  • Adheres to all divisional and site-specific policies, guidelines, and procedures.
  • Demonstrates Environmental, Health & Safety (EHS) leadership behaviors, actively participating in safety walks and related activities.
  • Develops SOPs, gap analyses, and procedures for Quality/EHS subsystems in compliance with regulatory requirements.
  • Demonstrates leadership qualities as per company standards.
  • Pursues personal career development through Performance Management Process (PMP), Employee Development Plan (EDP), and career mapping.
  • Performs any other duties as assigned by the Supervisor.

WHAT YOU MUST HAVE

Qualification:

Bachelors, Masters or Ph.D. degree in a technical field, such as Chemical or Mechanical Engineering or Pharmaceutical Sciences

Experience:

3 to 5 years of technical experience in the pharmaceutical manufacturing industry

WHAT YOU CAN EXPECT

  • Abundant opportunities across various areas in Manufacturing; well-defined career progression
  • A cutting-edge facility catering to global customers
  • Collaborative team focused on shaping the future

Our Manufacturing & Supply Division aims to be the most reliable supplier of biopharmaceuticals globally. Together with our partners, contractors, and suppliers, we form a global manufacturing network dedicated to providing high-quality, timely supplies to customers and patients worldwide.

We value diversity, talent, and commitment, fostering an inclusive environment where breakthrough innovation thrives through diverse ideas. We encourage respectful challenges and collective problem-solving. As an equal opportunity employer, we are dedicated to building an inclusive and diverse workplace.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/13/2024

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R294018

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