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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.

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

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.

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

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.

Manufacturing Biotechnologist Upstream 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 experience, experienced in GMP and/or Upstream. Fresh graduates are 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 Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

CONTACT OUR OFFICES SINGAPORE OFFICE: NUSANTARA PRIME CONSULTING (NPC) 12 Arumugam Road, #06-04, LTC Building B Singapore 409958 hello@nusaprime.com INDONESIA OFFICE: PT ATUI (PT ANTERO TEKNIK UNGGUL INDONESIA) CYBER 2 TOWER, 18TH Floor JL H.R. Rasuna Said Blok X-5, Kav 13 Kuningan Timur, Setiabudi Jakarta Selatan – DKI Jakarta hello@ptatui.com Thanks for submitting! Submit If you're interested to be part of the team, please 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? EMBRACE SUSTAINABILITY 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. Whatever your needs may be, we can make it happen. Get in touch with us today. Learn More OUR OFFERINGS Discover Our Expertise ENGINEERING DESIGN SOLUTIONS Achieve Your Goals Read More CONTACT OUR OFFICES SINGAPORE OFFICE NUSANTARA PRIME CONSULTING (NPC) 12 Arumug am Road, #06-04, LTC Building B Singapore 409958 admin@nusaprime.com INDONESIA OFFICE: PT ATUI (PT ANTERO TEKNIK UNGGUL INDONESIA) CYBER 2 TOWER, 18TH Floor JL H.R. Rasuna Said Blo k X-5, Kav 13 Kuningan Timur, Setiabudi Jakarta Selatan – DKI Jakarta rudy.siswanto@ptatui.com Thanks for submitting! Submit