Job Scope
- Hand on experiments to establish or assist an auto-production platform on the manufacturing scale;
- In charge of IOQ, Process validation, and Process transfer and complete the relevant reports from time to time;
- Supports the 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;
- Establish the manufacturing protocols, reports, and other associated documentation related to a new product introduction. Expected to have a working knowledge of product development, scale-up, technical transfer, supporting documentation, and compliance with the regulatory requirements. Demonstrates strength in technical writing for change requests, PPQ reports, and CMC sections.
- 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 the experiment/evaluation;
- Provides technical guidance to support the site and divisional projects, ensures that the process design is well-thought-out and robust for routine manufacturing;
- Provide technical input independently to the process design, process modification, and scandalization to ensure its fit for purpose for routine manufacturing;
- Provides technical advice related to the product, equipment, and manufacturing/cleaning processes in response to deviations/ product complaints/ adverse events to identify the point of occurrence, root cause, and corrective/ preventative actions;
- Help to establish product portfolio activities. Examples (but not limited to) include managing documentation updates (e.g. SOPS, batch records, recipes, reports), 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;
- Ensures optimum production runs, identifies constraints and non-conformances, and troubleshoots to resolve issues in production systems;
- 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;
- Besides, guide 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 and promotes Environmental, Health & Safety (EHS) leadership behaviors, ensuring that all activities are carried out per EHS requirements.
Requirement
- Candidates possess at least a bachelor's Degree in Materials Science, Chemical Engineering, Chemical and Biomolecular, Material Engineering, Pharmaceuticals Science, or a related discipline; Fresh graduates are welcome to apply;
- Diploma holders with at least 1 year of experience in the process role are welcome to apply for the assistant role;
- Able to multi-task and work in a fast-paced environment;
- Candidate's previous internship experience in the process engineer role or production roles; Hands-on experience on DCS, and PLC systems will be preferred;
- Ability to work independently, as well as in teamwork;
- Eager to learn and with minimum supervision;
- Experienced in pharmaceutical or medical-related manufacturing-related roles is an added advantage;
- Strong technical, detail-orientated, with analytical and problem-solving skills;
- Good communication and excellent interpersonal skills;
- Knowledge of ISO 13485:2016 quality requirements is an advantage but not compulsory.
Job Type
Full-Time/Permanent [contract-based for the assistant role].
About the Company
N-Lab Technology Center Pte Ltd is a local company in Singapore since year 2018. Through years of R&D studies in the In-Vitro Diagnostic (IVD) industries, we are proud to provide our customers with high-quality magnetic beads based on their requirements. We focus on two fields of research and experimental development: (1) on chemicals, such as magnetic beads with application in the In-Virto Diagnostics (IVD) field; and (2) on advanced materials in medical applications.
As the company expands, we need more talented people like you, who have a strong interest in the medical-related company and are passionate about their roles. If you are interested in starting your career in the IVD industry-related field, understand how polymer science can lead to technology improvement, are passionate about research and development, eager to learn hands-on experiences and skill-building for your career path, then do not miss this opportunity!
