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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.

NPCyclopedia Interested to find out more? Email us at hello@nusaprime.com ROOT CAUSE ANALYSIS TOOLS Root Cause Analysis is the process of discovering the root causes of problems in order to identify appropriate solutions. Next PROBLEM-SOLVING AND DECISION-MAKING Find out the 4 key aspects of problem-solving and decision-making Next

Quality Validation Specialist Responsibilities: Provide Quality oversight to equipment/system qualification, automation qualification (PCS/BAS) and cleaning validation Review and approve validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines timely Review and approve as needed, qualification/validation executed package validation exceptions, deviation, and investigations encountered during qualification/validation representing Quality Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities Participate in site Validation Maintenance Program Any other tasks as and when assigned by supervisor Support other technical changes and duties as require About You: Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science At least 5 years qualification/validation experience Possess process automation experience will be the additional benefit to be considered Communicate well, self driven, motivated and able to work well with others Based in Tuas Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

QC LEQ Engineer Responsibilities: Responsible for managing and writing of qualification related documentation but not limited to Qualification Plan and IQ, OQ, PQ and ERES Test Scripts for QC laboratory equipment (lab bench and CSV system) Responsible for overseeing execution of but not limited to IQ, OQ, PQ and ERES Test Scripts of QC laboratory equipment (lab bench and CSV system) and test script for new equipment deployments. Manage and maintain the progress tracking matrix on document generation, qualification execution, document review and approval. Escalate the issue/delay to management team. Coordinate and manage deviation to be initiated, assessed and closed out in timely manner. Responsible for stakeholder management including coordination with QC lab team on equipment availability for qualification activity. Responsible for all other activities related to qualification activities but not limited to change control, tag out, PM/Calibration program, equipment configuration, SOP generation. Work with IT team to develop the CSPECs, ERES etc to fulfill Part 11 requirement. Responsible for managing computerized system validation lifecycle data integrity portion and risk assessment. Handover and coordination post LEQ execution to QC lab Any other task as assigned by Supervisor/Manager About You: Bachelor in Engineering, Sciences, Business, Information Systems or equivalent. Min 5 years of experience in QC Lab Equipment Qualification in pharma or biotech facility. Knowledge of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility Good interpersonal, communication and presentation skills. Must be a self-starter, fast learner, curious with strong analytical and organizational skills Self-motivated and willingness to learn Reliable and Responsible Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

Manufacturing Specialist Responsibilities: Monitor, optimize, and troubleshoot issues related to either fermentation/cell culture or protein purification processes and unit operations. Perform product quality impact assessments and support root cause assessments for process discrepancies and Quality investigations. Identify and implement corrective actions, preventative actions and continuous improvements for process and equipment. Create, review and revise cGMP documents such as batch records, SOPs, etc. Create change records. Perform gap and technical assessments for global standards and procedures (GSPs and SOPs). Serve as risk lead or subject matter expert in support of risk assessments and hazards analysis e.g. microbial control risk assessments. Develop technical training material and conduct technical training for production staff. Support the technology transfer of new products/processes e.g. perform field testing. Create, review, revise and approve technical reports and engineering documents such as URS, FS, SDS, P&IDs, etc. Design, procure, commission, and qualify new equipment. Work effectively as part of a team responsible for ensuring successful and efficient processes for the production of recombinant proteins. Serve as subject matter expert for regulatory inspections as well as internal audits and support inspection response. Serve as RSTO representative in global network teams such as UOTs and task forces. Experience in Downstream operations for Drug Substance Manufacturing Operations will be an advantage Collaborate with multidisciplinary teams to achieve project objectives. Assist in experimental design and troubleshooting as needed. About You: Min. 5 years of experience Bachelor's degree in a relevant life science field (e.g., biology, biotechnology, biochemistry). Previous experience in a 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. 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

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!

Upstream MSAT Specialist Responsibilities: Perform routine lab cell culture tasks, including subculturing, passaging, and maintaining cell lines in compliance with established protocols. Monitor cell health, viability, and growth characteristics, reporting any deviations or anomalies promptly. Prepare and sterilize cell culture media, supplements, and reagents. Ensure accurate documentation of media preparation procedures and maintain inventory levels Adhere to rigorous quality control standards to ensure the integrity and purity of cell cultures. Maintain detailed records of all cell culture activities, documenting parameters such as cell counts, passage numbers, and viability. Ensure cleanliness and organization of the laboratory space, including benchtops, equipment, and storage areas Dispose of biological waste and hazardous materials in accordance with safety guidelines and regulations. Operate, clean, and maintain laboratory equipment, including incubators, biosafety cabinets, centrifuges, and microscopes. Report any equipment malfunctions or irregularities to the supervisor for timely resolution. Implement and uphold strict aseptic techniques to prevent contamination of cell cultures. Perform routine cleaning and sterilization of work areas and equipment to maintain a controlled environment. Contribute to the development and optimization of protocols for cell culture procedures. Collaborate with peers and supervisors to design and validate new experimental techniques. Generate comprehensive reports summarizing experimental procedures, results, and observations. Compile and analyze data, ensuring accuracy and completeness prior to submission. Collaborate with multidisciplinary teams to achieve project objectives. Assist in experimental design and troubleshooting as needed. Perform any other tasks as assigned by the manager. About You: Diploma/Bachelor's degree in a relevant life science field (e.g., biology, biotechnology, biochemistry). Previous experience in cell culture techniques and aseptic procedures is required. 3-6 years lab cell culture experience is preferred. Familiarity with laboratory equipment and techniques associated with cell culture operations. 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 Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

Senior Validation Engineer Responsibilities: Develop, review and/or approve validation lifecycle documents and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion. Lead project validation activities, and provide basic guidance and direction to junior project engineers as required. Review Turnover / Vendor Packages as part of the project deliverables to support qualification activities. Manage qualification execution and lead validation deviation investigation encountered in qualification. Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities. Able to manage cross functional stakeholders, and to lead / facilitate meeting and discussion relevant to project qualification/ validation activities. Participate in site Validation Maintenance Program. Support Change Implementation on site. Any other tasks as and when assigned by Supervisor or Project Lead. About You: Engineering/Science Degree or higher from recognised institution At least 5 years of experience in Cleaning validation and Equipment Qualification in the pharmaceutical/biotech industry. Experience in Critical Utilities, and temperature mapping is preferred. Good knowledge and experience of the practical and theoretical requirement of validation program in GMP facility Good oral and written communication skills Meticulous and Systematic Team player, with strong focus on safety, quality and timeline Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

PAST PROJECTS NUSANTARA PRIME CONSULTING solves each client’s issues by providing a comprehensive approach backed by our team of experienced professionals. Our process fosters collaboration and innovation to ensure we not only understand the core needs of clients, but also help them develop successfully. Read our success stories below. PERMITTING FOR 70 WIND TURBINES Clients often approach NUSANTARA PRIME CONSULTING with a general idea of what they need, and this project was no different. We were able to jump right in with our expertise and really helped the company grow and evolve. Today, their business is doing exceptionally well, and we’re proud to have been part of the process. SOLAR ENERGY INSTALLATION Often times our clients have everything they need to succeed, they just require the resources and support to make a strategic jump. We worked on this project for several months and the end result was truly spectacular. By ensuring consistent and transparent communication, our client was able to progress by leaps and bounds. AIR POLLUTION CONTROL We approached this project carefully, as it was our very first undertaking of this scale. We studied our client’s business to create a focused and effective solution - and then watched it grow. We loved working with this client, and look forward to collaborating together on many more successful projects in the future.