Search Results

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.

Project/ Process Support Engineer Responsibilities: Lead projects through the design, procurement, installation and commissioning of new equipment or modifications to existing equipment, facilities and engineering assets, in order to meet operational and reliability requirements for existing product and/or new product introduction. Collaborate with internal resources and/or external contractors to plan, schedule and execute capital projects within established timelines and budgets. Ensure equipment and piping design conforms to industrial standards, master specifications, statutory requirements, SHE standards, cGMP compliance and other necessary requirements. Create, review and/or approve cGMP documents such as SOPs, engineering drawings, change orders, etc. and maintain project documentation as necessary. Partner with maintenance and utility teams to ensure maintenance requirements are duly considered in asset design, support updating of maintenance procedures/work instructions and imparting capabilities for asset maintenance. Partner with reliability teams to provide information for setting up maintenance master data, contribute to total asset lifecycle management and support reliability initiatives for all F&E assets. Assist in preparation of capital budget. Support the technology transfer of new products/ processes to the Singapore site as required. Support qualification of new equipment or modifications to existing equipment as required. Support risk assessments, impact assessments and implement CAPA as required. Support in raising Planned event records in Veeva change management system to get GMP impacting project scope approved for execution. Comply with site Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable. Observe all site security measures at all times, and report any suspicious characters/objects & damaged security mechanisms to Site Security immediately. Embody PT Lean Production System (LPS), while demonstrating a continuous improvement mindset and behaviors through the use and application of LPS tools for continuous improvement initiatives. About You: Bachelor of Science/Engineering or higher in a scientific or engineering discipline At least 5 years' experience as a design/project engineer/process engineer or related technical discipline in the pharma/biotech industries. Advanced knowledge of engineering concepts, master specifications, equipment validation and qualification, safety principles, quality systems and cGMP requirements.Working knowledge of site finance and procurement policies relating to capital projects. Working knowledge/experience of procedures related to construction, field safety, welding/installation, passivation, polishing and cleaning etc. Experience in working with Veeva planned events change management systems is preferred. Able to develop solutions to complex problems using sound engineering judgment and advanced engineering knowledge. Must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills. Core Competencies: Willingness to embrace change, ability to adapt to rapidly changing circumstances and courage to challenge status quo when necessary with a view on continuous improvement and achieving targets. Goal-oriented, persistent and driven to achieve results. Willing to take accountability for his/her job assignments. Strong aptitude to acquire and apply engineering knowledge and project management skills. Positive attitude towards continuous learning and contributing his/her expertise within and beyond the assigned work area. Works effectively with other colleagues and partners. Ability to foster a good exchange of ideas from working teams and communicate effectively to members of the project team and stakeholders. Think beyond department and functional boundaries. Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

2023 ISPE Singapore Affiliate Conference & Exhibition The ISPE Singapore Affiliate Conference & Exhibition is one of the largest and most respected pharmaceutical manufacturing shows in Singapore for pharmaceutical and biomanufacturing professionals. The annual event highlights the best practices and services from manufacturing facility design to finished products. This year, NPC and CoBetter participated in ISPE 2023 to give product awareness on filtration and single-use products from 23rd to 25th August 2023 at Suntec, Singapore. WhatsApp Image 2023-09-05 at 12.01_edited 1/4 NPC x Cobetter at booth #411.

Quality Validation Specialist Responsibilities: Provide Quality oversight to Cleaning, Standardization and Optimization projects. Review and approve acceptance tests/reports in accordance with relevant policies, standards, procedures, and guidelines timely. Review and approve as needed, qualification/validation exceptions, deviation and/or investigations encountered during acceptance test execution representing Quality. Collaborate with multi functions to arrange, plan, and ensure smooth running of the execution activities. Any other tasks as and when assigned by the supervisor. Support other technical changes and duties as required. About You: Bachelor of Science/Engineering or higher in a scientific or engineering discipline Possess minimum 5 years of qualification/validation experience. Must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills. Must be team player, meticulous, strong communication, analytical and organizational skills 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.

Quality Operation Associate Responsibilities: Ensure that products manufactured meet approved company policies, processes and procedures Provide quality oversight of GMP manufacturing and manufacturing support, including technical operations, engineering, QC laboratory and supply chain activities. Review completed incoming material inspection packages, Batch Records, Manufacturing Logs, product changeover/line-clearance activities and administration of Quality Logs, e.g., QA Hold, QA tag out. Release incoming material, process, and product batches. Participate in investigations arising out of non-compliance in incoming materials, QC testing, manufacturing processes, warehousing, and product. Participate in change management, including change coordinator and/or QA oversight roles to ensure change plan is managed and complies with applicable policies. Perform regular walk-through of manufacturing, engineering, warehouse and QC areas as required to ensure compliance is maintained at all times. Participate and support new product introduction, operation excellence projects and other tasks as assigned by management About You: Bachelor Degree in a Natural Sciences (i.e. Biology, Chemistry), Engineering, Pharmacy or other relevant courses Prior knowledge of quality / compliance management as well as regulations and standards affecting APIs / Biologics Minimum of 2+ years of pharmaceutical, biopharmaceutical experience in Quality and/or Compliance (GxP) environment. Experience in SAP, Trackwise are preferred Ability to quickly know products and processes in order to assess quality issues Committed to quality and maintain a high standard of work at all times Demonstrates the highest levels of integrity and a strong work ethic Good knowledge of GxP requirements and regulations Good planning and scheduling skills Good communication and interpersonal skills both verbal and written Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

PIONEERING LEAN, HOLISTIC SOLUTIONS FOR PHARMACEUTICAL , LIFE SCIENCES AND F&B INDUSTRIES ACROSS ASIA HOW DO WE DO IT? GET TO KNOW US NUSANTARA PRIME CONSULTING is a Singapore-based company that focuses on technical consulting solutions led by a team of industry practitioners. We have been delivering solutions to clients since 2019 with an impressive portfolio of professional consulting services that are completely customizable for your business. Interested to be part of us? Submit your resume to recruitment@nusaprime.com OUR OFFERING S Whatever your needs may be, we can make it happen. Get in touch with us today. BOOK CONSULTATION Design Solution PRojects staff augmentation technology transfer management validation support health authority audit training expansion consultation waste management consulting mes technology support Contact Us Address Location Singapore Office NUSANTARA PRIME CONSULTING (NPC) 12 Arumugam Road, #06-04, LTC Building B Singapore 409958 Contact Phone Mail : +65 6910-8368 : hello@nusaprime.com : NUSANTARA PRIME CONSULTING PTE LTD (Nusaprime) Location Indonesia Office PT ANTERO TEKNIK UNGGUL INDONESIA (PT ATUI) CYBER 2 TOWER, 18TH Floor JL H.R. Rasuna Said Blok X-5, Kav 13 Kuningan Timur, Setiabudi Jakarta Selatan – DKI Jakarta Mail : rudy.siswanto@ptatui.com : PT Antero Teknik Unggul Indonesia

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.