Process Engineer, PTO

Job Description**Process Engineer****THE OPPORTUNITY*** **Be part of the team that ensures sustainable products meets standard quality and committed to deliver to customers worldwide*** **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 three consecutive years (2020, 2021, 2023).*** Join the **premier biopharmaceutical company** that has been **in Singapore for more than 25 years and in AP for over 60 years.**Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.**Job Purpose**The PTO Process Engineer/Chemist provides technical supply support on the commercialization and manufacture of all drug products with minimal support from seniors or direct supervisor (seeking support/ escalating efficiently where needed). He/ she supports all technical/ process activities (for example) investigations, validation and qualification processes, risk assessments and process safety management activities under his/ her responsibilities.**What will you do:*** 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. Expected to have a basic knowledge of product development, scale-up and technical transfer, key supporting documentation and associated regulatory requirements. 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. Proactively identify solutions with support from seniors or direct supervisor to address issues that arose during experiment/evaluation.* Support site and divisional capital projects and new facility start-up activities if applicable. Provide technical input to the process design to ensure it is fit for purpose for routine manufacturing in collaboration/support from colleagues. Responsible to transfer the knowledge of the project and facility to Integrated Process Team (IPT) colleagues.* 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.* Provide technical support for compliance activities such as audit and regulatory support. Collects data and documents to be presented to regulators during site inspections and for regulatory submissions. Demonstrates an understanding of the manufacturing lifecycle of a product including technical requirements, analytical regulatory guidelines/expectations associated with global regulatory submissions.* Supports product portfolio activities. Examples (but not limited to) include managing documentation updates, SOPs, batch sheets, 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 basic knowledge of respective compliance topics related to the above-mentioned activities and Quality by Design (QbD) and executes the requirements in support of a QbD filing where applicable.* Support routine supply manufacture by providing ongoing technical support to the IPT, participates in Tier processes and implement opportunities for improvement utilizing Production Systems tools. Support the activities and Quality by Design and executes the requirements in support of a QbD filing where applicable.* Supports routine supply manufacture by providing ongoing technical support to the IPT, participates in Tier processes and implement opportunities utilizing Production System tools. Support the activities to ensure optimum production runs, constraints and non-conformance identification and troubleshoots to resolve basic issues in production system.* Proactively monitors the performance of process parameters, critical quality attributes and equipment/module/unit operations performance during manufacturing and cleaning. Participates in Prospective Process Analysis (PPA), statistical analysis and response to shifts and trends in process performance. In addition, participates in Continued Process Verification and Annual Product Review activities as part of product lifecycle management. Demonstrates basic knowledge of statistical and risk analysis tools to identify action required to ensure product robustness across various types of manufacturing equipment and processes. Demonstrates understanding of product CPP, CQA, CpK and where applicable, sterile boundary of the current validated processes. Familiar with raw materials and PCC (product contact components) used for the products under his/her responsibility.* Participates in the collaboration and sharing of best practices across global company network.* Complies with all divisional and site-specific policies, guidelines and procedures. Demonstrates and promotes Environmental, Health and Safety (EHS) leadership behaviours, ensuring that all activities are carried out in accordance with EHS requirements. Actively participates in GEMBA safety walks. participates in process hazard analysis (PHA), and applicable process safety management (PSM) activities related to the new/inline products.* Where applicable, develops SOPs, gap analyses and procedures for Quality/EHS subsystems/topics in compliance with regulatory requirements, divisional and corporate policies and guidelines.* Demonstrate leadership behaviours in alignment with Company Leadership standards (Individual Contributor). Practices Inclusion as the How. Engages in 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 the Supervisor.**What you should have:*** Bachelors, Masters or Ph.D. degree in a technical field, including Chemical or Mechanical Engineering, Chemistry, Biological sciences or Pharmaceutical Sciences* 1 to 2 years of pharmaceutical experience preferred. Fresh graduates are encouraged to applyOur 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 driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.**WHAT YOU CAN EXPECT*** Limitless opportunities across various areas in Manufacturing; well-structured career pathA state-of-the-art facility that delivers solution to its customers world-wideWe are proud to be a company that embraces the value of bringing diverse,
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