MSD Senior Process Engineer PTO 

Singapore, Singapore 

533318276

Job Description

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 (2021, 2022, 2023).
• Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years.
• 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 Pharm Tech Operations (PTO) Senior Process Engineer supports/leads the source of supply changes, introduction of new products to the site and/or the transfer of drug products to other facilities either independently or with minimal 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. They also support continuous process improvement activities to enhance site performance metrics and contributes to the global company technical network to share site experiences/knowledge and continue to expand on personal expertise. They also provide technical supply support on the commercialization and manufacture of all drug products. They support the objectives of his/her seniors/direct supervisor.

• Supports or leads (with minimal guidance) new product introductions to the site by conducting process and equipment comparisons, new raw materials 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. Expected to have a working knowledge of product development, scale-up and technical transfer, key supporting documentation and associated regulatory requirements. Demonstrates strength in technical writing for change request, PPQ reports and CMC sections.
• Is involved in and 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 duringexperiment/evaluation.
• Provides technical guidance in support of site and divisional capital projects and new facility start-up activities. Ensures that the process design is well thought-out and robust for routine manufacturing.Provide technical inputindependently to the process design to ensure its fit for purpose for routine manufacturing. Responsible to transfer the knowledge of the project and facility to IPT colleagues.
• Provides technical expertise related to the product, equipment and manufacturing/cleaning processes in responsetodeviations/ product complaints/ adverse events to identify point of occurrence, root cause and corrective/ preventativeactions.
• Provides technical expertise for compliance activities such as audit and regulatory support. Monitors and addresses potential regulatory risks during various phases of the lifecycle process independently or as part of a team.
• 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 tothe above-mentioned activities.
• Supports routine supply manufacture by providing on going technical support to the IPT, participates inTierprocesses and implement opportunities for improvement utilizingcompany productionsystem tools. Ensures optimum production runs, identifies constraints and non-conformances and troubleshoots to resolve issues inproductionsystems.
• 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 applicablemanufacturingequipment and processes.
• Demonstrates good understanding of product CPP, CQA and/or Cpk 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.
• Actively participates and shows commitment to collaboration and sharing of best practices across the globalcompanyS&T network.
• Complies with all divisional and site-specific policies, guidelines andprocedures.
• Where applicable, develops SOPs, gap analyses and procedures for Quality/EHS subsystems/ topics in compliance with regulatory requirements, divisional and corporate policies and guidelines.
• Demonstrates leadership behaviors in alignment withcompanyleadership standards (Individual Contributor).
• Leads personal career development with manager assistance through annual Performance Management Process (PMP), Employee Development Plan (EDP) and career mapping.
• Any other duties as assigned by theSupervisor.

WHAT YOU MUST HAVE

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

3 to 5 years technical experience in pharmaceutical manufacturing industry

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

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