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CQV Lead Responsibilities: Lead a team of engineers in the delivery of commissioning activities/ qualification activities/automation I/O checks on all associated equipment to ensure CQV execution phases progress as per schedule. Review of Commissioning, Qualification Verification (CQV) documentation Loops packs for all associated equipment Field execution and supervision of Loop checking and Calibrations of process, equipment and clean & black utilities Attend regular client meetings to present on progress Co-ordination/review of vendor packages to achieve streamlined CQV Co-ordination/Review of construction packages to achieve streamlined CQV About You: Degree in Engineering or Science and a minimum of 5 years of experience within a Life Sciences environment Relevant experience working on process equipment, Clean utilities and facilities Hands on validation execution experience Experience in leading daily validation meetings with cross functional in resolving validation issues. Experience of working in a project environment Strong stakeholder management skills Excellent oral and written communication skills in English Self starter and able to drive project timeline Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

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Senior Manufacturing Engineer Responsibilities: Responsible for handling the development of operation protocols for upstream or downstream operations starting from the dispensary of raw materials up to end of the manufacturing process. Lead and execute multiple Change Records (Planned events) for the assigned area for creation of new Batch Records and Standard Operation Procedures for Production Support Change Records Assessment and GMP documentation Review. Responsible for providing support to the assigned manufacturing operations by developing, coordinating, and facilitating small to medium projects to ensure planned, predictable production operations in compliance with GMP regulations. Lead and execute Continuous Process Improvements, CAPAs and Change Records in the assigned area. Provide routine and ad hoc support for planning, coordinating, execution, and performance improvement of key manufacturing processes such as product change over. Lead project teams to troubleshoot medium to complex problems and support continuous process improvement. Facilitate root cause analysis (RCA) with input from SMEs, develop and implement change to improve performance. Collaborate with multidisciplinary teams to achieve project objectives. Assist in experimental design and troubleshooting as needed. About You: Bachelor's degree in a relevant life science or Engineering field (e.g., biology, biotechnology, biochemistry). At least 5 years of experience in the Manufacturing / GMP environment is preferred. Strong attention to detail, organizational skills, and the ability to work independently or in a team. Excellent communication skills, both written and verbal, in English. Adherence to safety protocols and regulatory compliance.Adherence to safety protocols and regulatory compliance. Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

Ready to take the next step in your career? Join our dynamic team, and become a part of the NPC community. PHARMA/BIOTECH Process/Project Engineer ​ This position is responsible for the validation of enterprise resource planning systems, automated equipment and/or control systems. Familiarity in DCS (Distributed Control System), PLC/SCADA and OSI PI is a plus. In this role, the engineer has to work in accordance with the company’s policies and procedures to ensure validation is performed in accordance with quality requirements and regulations. Manufacturing Biotechnologist Downstream/Central Services (Pharma/Biopharma) ​ The candidate will be expected to support day to day production activities and troubleshoot process related issues. Manufacturing Engineer ​ Candidate is responsible for leading the development of operational protocols, execute Change Records and Continuous Process Improvements, manage projects, troubleshoot issues, and collaborate for enhanced manufacturing processes in compliance with GMP regulations. CQV Engineer ​ The candidate is responsible to support equipment qualification, system qualification and cleaning validation. In this role, the engineer must ensure qualification activities are performed in accordance with the company’s policies and procedures, and regulatory requirements. CSV Engineer ​ This position is responsible for the validation of automated equipment and/or control systems. Familiarity in DCS (Distributed Control System), PLC/SCADA and OSI PI is a plus and also have thermal mapping experience. In this role, the engineer has to work in accordance with the company’s policies and procedures to ensure validation is performed in accordance with quality requirements and regulations. QA Production Associate ​ Responsible for providing oversight for Quality on-the-floor and operations support, the QA Associate will support manufacturing operations and IPC testing through purposeful presence on the floor, and support of complex manufacturing investigations, change control, and unexpected result investigations. Required to perform a 12-hour shift (full night shift preferably). Senior Validation Engineer ​ Support equipment qualification, system qualification, and cleaning validation. Quality Operations Specialist ​ Quality Operations Specialists must assist site management to oversee the quality system execution on the manufacturing and production areas at all times. The personnel are required to observe, document, discuss, and report quality adverse events related to the manufacturing of the product and are responsible to ensure highest quality and compliance of released batches. Manufacturing Biotechnologist Upstream ​ As our Biotechnologist, you will be expected to perform routine manufacturing processes and troubleshoot process related issues. ​ ​ Validation Engineer ​ The candidate is responsible for supporting validation activities including develop, support and implementation. In this role, the engineer has to ensure qualification activities are performed in accordance with the company’s policies and procedures, and regulatory requirements. EHS Engineer (F&B Alternative Food Technology) ​ This role involves supporting the development and implementation of EHS policies. It also includes conducting risk assessments, enforcing safe management measures, coordinating audits, maintaining safety documentation, and overseeing workplace safety, including drills and emergency management exercises. Process Engineer (Active Pharmaceutical Ingredient) ​ This role involves leading improvement initiatives for manufacturing processes, supporting operational efficiency goals, troubleshooting process, equipment issues, conducting risk assessments, and ensuring quality documentation for SOPs, reports, and protocols. Laboratory Analyst (Pharma/Biotech) ​ The position involves conducting biochemistry and analytical testing for lot release of products, ensuring compliance with quality standards, maintaining laboratory equipment and cleanliness, supporting operations like method transfer and documentation management, and participating in regulatory audits and continuous improvement initiatives. Interested to be part of our team? Please submit your resume to recruitment@nusaprime.co m and indicate your interested job position. 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.

Warehouse/Logistics Assistant Responsibilities: Ensure accurate and timely receiving and issuance of materials to production from internal warehouse and 3PL to ensure no production stoppages. Raising of materials damage report, materials disposition authorization and any other document to track the movement of inventories Ensure all transfer order transaction in SAP system are completed accurately as per physical movement Support and assist in investigation for any inventory discrepancies, violation of GMP and EHS procedure Responsible for raw materials sampling for laboratory testing according to standard. Involve in routine cycle counting activities which may include physical counting, count check, count verify and data entry of count tabulation. Ensure all inventories are properly managed. Ensure all documentation is handled, filed properly and data are posted accurately in the SAP system. Support for all outbound land, sea and air shipments. Ensure shipments are pack and stuff on time for delivery. Operate all material handling equipment such as forklift and VNA with standard operating and safety procedure. Maintains all material handling equipment and vehicles in good working condition by ensuring preventive maintenance is performed timely. Maintains safe and clean work environment by keeping shelves, pallet area, and workstations neat. Experience in handling sterile and hazardous material Contribute in establishing warehouse SOP (Standard operating procedure) Any other duties assigned by the Superior. About You: Diploma in Supply Chain, ITE or an equivalent Minimum 1-3 years of relevant experience in GMP warehouse environment. Knowledge in GMP (Good documentation practices, sampling) is a must. Able to perform sampling of raw materials (solid and liquid) Able to adapt to changing work schedules and hours including overtime when required Ability to work in a fast pace and challenging environment A willing and engaging team player, contributing positively the team efficiency. Possess a valid forklift license will be an advantage. Able to operate stacker and VNA Prior experience working with SAP system is preferred Based in Tuas. Transport provided 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.

PIONEERING LEAN, HOLISTIC SOLUTIONS FOR PHARMACEUTICAL , LIFE SCIENCES AND F&B INDUSTRIES ACROSS ASIA HOW DO WE DO IT? 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 Consulting 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 :hello@ptatui.com : PT Antero Teknik Unggul Indonesia