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EHS Engineer (F&B Alternative Food Technology) Responsibilities: EHS Area: To conduct safety briefing to new employee/ contractors/ vendor/ Visitors To conduct regular safety talks to each shift team Support development and implementation of EHS policies To Promote safety initiatives and enhance safety culture in Singapore Operations Conduct risk assessment, job hazard analysis etc and enforce safe management measures. Perform ongoing inspection and safe management measures to identify non-conformity (e.g. not using protective equipment) Coordinate audit related matters and maintain safety documentations. Facilitate and carry out monthly EHS Committee meetings Maintain compliance and updates on new WSH regulations. To collect data the support EHS or Sustainability monthly report/ project etc Continue enhance on current EHS or Sustainability guidelines for SG Operations Coordinate Permit to Work System for plant operations and ensure contractors are fully inducted onto sites and comply with standards Oversee workplace repair, installations and any other work that could have potential risk to safety Verifies that all tools and equipment are adequate and safe for use. Register and investigate WSH incidents and provide statistical information. Conduct safety briefings and trainings according to plans or as and when required Carry out drills and exercises on emergency management. Arrange for OSHA mandated testing and/or evaluations of the workplace by external agencies/consultants. Other duties as assigned Security Area: Incharge of the proxy click system and ensure all visitors are registered. Work closely with area owners to investigate and act immediately on all disciplinary offences. Facility Area: To coordinate with the landlord (YHS) and all other contractors/ vendors as required to properly maintain and manage the local facilities at L10 manufacturing and L2 office area. To conduct routine checks and supervise minor repairs/ replacement works with contractors as part of the safety act. To work closely with L10 and L2 area owner regarding facility maintenance work About You: Degree/ Diploma in Engineering or related equivalent Minimum 1-2 years of relevant experience in SHE management or similar Strong understanding on local legislations and procedures related to SHE Very good understanding of the SHE system Demonstrable following experiences: Experience with establishing SHE policy & procedure Excellent knowledge of potentially hazardous material and practices Hazard and risk management Emergency preparedness Experience in performance analysis, reporting and investigation Behavioural auditing Proficient in MS office application Enjoy problem solving, analytical and a good team player Strong communication skills, organized and good interpersonal skills Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

Root Cause Analysis Tools Ishikawa Fishbone Diagram The model introduced by Ishikawa (also known as the fishbone diagram) is considered one of the most robust methods for conducting root cause analysis. This model uses the assessment of the 6Ms as a methodology for identifying the true or most probable root cause to determine corrective and preventive actions. Five Why's This model uses the 5 Why by asking why 5 times to find the root cause of the problem. It generally takes five iterations of the questioning process to arrive at the root cause of the problem and that's why this model got its name as 5 Whys. But it is perfectly fine for a facilitator to ask less or more questions depending on the needs Failure Mode and Effects Analysis (FMEA) FMEA is a technique used to identify process and product problems before they occur. It focused on how and when a system will fail. Pareto Chart The Pareto Chart is a series of bars whose heights reflect the frequency or impact of problems. On the Chart, bars are arranged in descending order of height from left to right, which means the categories represented by the tall bars on the left are relatively more frequent than those on the right. Scatter Diagram A scatter diagram also known as a scatter plot is a graph in which the values of two variables are plotted along two axes, the pattern of the resulting points revealing any correlation present. Affinity Diagram Also known as KJ Diagram, this model is used to represent the structure of big and complex factors that impact a problem or a situation. It divides these factors into small classifications according to their similarity to assist in identifying the major causes of the problem Fault Tree Analysis (FTA) The Fault Tree Analysis uses Boolean logic to arrive at the cause of a problem. It begins with a defined problem and works backward to identify what factors contributed to the problem using a graphical representation called the Fault Tree. It takes a top-down approach starting with the problem and evaluating the factors that caused the problem. Managers' Talk "Deviations are measured differences between observed value and expected or normal value for a process or product condition, or any departure from a documented standard or procedure. From the agency's perspective, any deviation should be documented and explained. Critical deviations should be investigated, and the investigation and its conclusions should be documented. Deviation investigation (root cause analysis) aims to determine the root cause of the problem and to provide adequate correction and preventive actions. There are different tools to be utilized in deviation investigations, such as 5Whys analysis and fishbone diagram. Depending on the deviation and rigor, different tools can be used in a RCA. " Kek Xing Yi | Head of Technical Validation

Manufacturing Biotechnologist (Downstream/Central Service) Responsibilities: Perform routine manufacturing processes and equipment preparation (CIP, PT, SIP, etc.) Support day to day production activities and record data according to Electronic Batch Record (EBR) in compliance with GMP, Environmental, Health and Safety guidelines. Perform equipment and process monitoring Able to communicate with Supervisor/supporting functions for any safety, quality, and process irregularities Troubleshoot and resolve process related issues. Able to perform production area housekeeping (5S, Kanban, etc.) Review documentation of activities as per GDP (Good Documentation Practice) Use sophisticated softwares / programs (LIMS, SAP, DCS, MES, etc.) to collect and evaluate data Responsible for maintaining and meeting training requirements. Any other task as assigned by Supervisor/Manager About You: Degree/Diploma/ITE in chemical engineering, pharmaceutical or biotechnology equivalent Minimum 1 year relevant biotechnologist/laboratory experience, familiar in GMP and/or Upstream/Downstream/Central Services. Fresh graduate is welcome to apply. Basic skills and knowledge in Fermentation Cell culture, Bioreactor processing, Media and Buffer Preparation and downstream processing is an added advantage. Able to do rotating 12-hour shift work. Team player that possesses troubleshooting and analytical skills. Must be able to carry heavy load of up to 10kgs where applicable. Based in Tuas Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

Validation Engineer Responsibilities: Support equipment/system qualification and cleaning validation Develop cleaning validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion Manage qualification/validation execution and lead the validation deviation investigations encountered during qualification/validation Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities Support Change Implementation on site Any other tasks as and when assigned by supervisor Support other technical changes and duties as required About You: Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science. At least 4 to 6 years qualification/validation experience. Cleaning validation experiences in Biologics and/API process. Based in Tuas Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

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Document Control Specialist Responsibilities: Ensure document Accuracy (Doc No, Dwg no, revision, formatting and etc) Assign document numbers for deliverables and non-deliverables Coordinate documentation flow process, delivery & return of documents in a timely manner Maintain an updated Master list and distribution matrix Manage vendor documents as per company’s requirements and maintain an up to date filing list. Coordinate & Maintain records of all requests for drawings, documents, tags, datasheet and etc To provide accuracy of documentation and to minimize error by maintaining an efficient filing system To upkeep and maintain ISO standards filling so as to retrieve information easily To develop proper coordination internally to ensure timely submission To keep track of outstanding transmittals Collate all project documentation & Transfer to archive at project completion About You: The candidate must have at least 3-5 years’ experience in the construction industry document control Must understand document management and numbering etc. Familiar with Microsoft software such as Access, Excel, Outlook, PowerPoint, Project, Visio, Word, etc. Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

Process Validation Engineer Responsibilities: Support process validation and characterization studies. Develop process validation and process characterization study protocols/reports in accordance with relevant policies, standards, procedures, and guidelines, and completed in a timely manner or in accordance with project timelines. Manage the execution of process validation and characterization studies and associated deviation investigations. Collaborate with cross-functional teams to arrange, plan, and ensure smooth running and execution of the process validation activities. Support relevant process and technical change management and change implementation activities. Support any other tasks as assigned by the supervisor. About You: Bachelor Degree in Engineering, Biotechnology, Science, Industrial Instrumentation and Process controls or related courses At least 5 years of relevant working experience in the Pharmaceutical / Biologics manufacturing industry with experience in process validation is preferred. Knowledge and ensure compliance with cGMP and safety regulations; Liaise with stakeholders to ensure proper implementation Demonstrated proficiency of written and verbal communication skills with ability to communicate and collaborate effectively with cross-functional teams Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

OUR STORY OUR STORY NUSANTARA PRIME CONSULTING was founded in 2019 with a single purpose to be the most successful and ground-breaking consulting agency; providing best-in-class services to support our customers in producing quality healthcare timely and economically . We're committed to providing companies and individuals with quality products and innovations in an industry that is constantly changing. The birth of the NUSANTARA brand: NUSA meaning “island ”, and ANTARA meaning “interconnection ” With a holistic thought process, we are dedicated to partnering with our clients on end to end solution support delivering life-saving therapeutic drugs to the patients OUR VISION To be the most successful and ground-breaking consulting agency; providing best-in-class products and services to support our customers in producing quality healthcare timely and economically. OUR MISSION With a holistic thought process, we are dedicated to partnering with our clients on end-to-end solution support delivering life-saving therapeutic drugs to the patients.

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OUR OFFERI NGS Our Specialist Services include focus on Process/Project Engineering and Design, Project Management, Facility expansion and improvement, Technology Transfer, Regulatory affairs, GMP & Audit Training, Commissioning, Qualification, Validation, Quality Assurance & Control, Process Development and Waste Water Treatment Processing consultation with aim of Zero Liquid Discharge (ZLD) for a circular economy to clients in the Biopharmaceuticals, API Pharmaceuticals, Life Sciences and Food & Beverage (F&B) industries in the ASEAN region. Design solution Conceptual, Basic, Detailed Designs projects Construction, Commissioning, Qualification staff augmentation Operation Support, Engineering Support, Quality Control & Assurance technology transfer management With the professional advice of our consultants Validation support Process Validation, Product Validation, Computer System (CSV), Cleaning Validation health authority audit training Technical Training for Staff expansion consulting Facility/Production Line Expansion, Improvement Support and Consulting, Process and Facility Debottlenecking Study MES EBR Setup, Planning, Implementation and Validation TEchnology support Product Supports and Digitalization waste management consulting ZLD = Zero Liquid Discharge product management ZLD = Zero Liquid Discharge Meet Our Clients YOUR GOALS IS OUR MISSION Begin your planning, with a consultation with us! Submit Thanks for submitting!