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  • Careers | NUSANTARA PRIME CONS

    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. OTHERS HR & Admin Assistant ​ Candidate is responsible for conducting daily administrative tasks and assist in human resource tasks and projects. In this role, individual will work with the management team to ensure smooth operations and to act as the first point of contact within a company for administrative or HR-related inquiries. ​ *Internship/Part-time options available Admin & Marketing Assistant ​ Candidate is responsible for conducting daily administrative tasks and managing company's social media account. In this role, individual will work with the management team to ensure smooth operations and to act as the first point of contact within a company for administrative or basic HR-related inquiries. ​ *Internship/Part-time options available Sales Executive (Bioprocess/Life Science) ​ The candidate is responsible for maxmising sale growth and driving presales activities to support the business. In this role, one is expected to build rapport with potential customers and secure new projects . 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.

  • Laboratory Analyst (Pharma/Biotech) | NUSANTARA PRIME CONS

    Laboratory Analyst (Pharma/Biotech) Responsibilities: Perform biochemistry, analytical and raw material of in-process and marketed products for lot release in accordance with quality standards and procedures Responsible for housekeeping duties in the lab. Perform Quality Tag Out for laboratory equipment such as freezer, water bath, etc. Support laboratory operations including but not limited to method transfer, equipment qualification, calibration, cleaning and maintenance, purchase and receipt of reagents and consumables, waste management, reagent and media preparation, critical reagent management and document management Review lot release data, identify testing discrepancies and participate in laboratory investigations Participate in inspection and ensure that the laboratory and documents are in a constant state of regulatory compliance and inspection readiness To assist in writing SOP documents, change plan or change records (document revisions) supporting continuous improvement of test procedures and assay sheet design To carry out completion and review of GMP Documentation of data sheets or LIMS software To carry out QC sample receipt, assay and release procedures Support Audit preparation and any audit related activity Reading and understanding the test procedure and the requirements per USP, JP and EP About You: Bachelor of Science majoring in Chemistry, Biochemistry or related scientific degree At least 1-3 years relevant experience depending on qualification, preferably in the bio-pharmaceutical / Pharmaceutical industry Good working knowledge of cGMP and regulatory requirements related to Quality is preferred Problem-solving and troubleshooting skills Highly motivated and independent Possess good interpersonal and communication skills Knowledge of cGLP / cGMP, FDA, EMA and ICH guidance and industry standards for analytical development and characterization Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

  • EHS Engineer | NUSANTARA PRIME CONS

    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.

  • Process Engineer (Active Ingredient) | NUSANTARA PRIME CONS

    Process Engineer (Active Pharmaceutical Ingredient) Responsibilities: Responsible for manufacturing process technical support and improvement initiatives for ongoing operations Support start-up and assist in plant equipment and facility validation and qualification activities Supports manufacturing activities during the technology transfer, qualification and validation batches associated with new product introductions to the site Supports operational efficiency goals for yield, product quality and other product and/or site KPI’s Contact and consultant for process/equipment troubleshooting and investigation activities Supports risk assessment activities providing relevant technical knowledge Provides support for process cleaning/changeover strategies Authors technical reports, batch records, SOP’s, investigations, protocols as required and ensures consistency and quality of the group’s documentation About You: Chemical Engineering with >5 years of experience in the area of API Manufacturing (Process Engineer) or Manufacturing, Science and Technology (MSAT) role Responsible for manufacturing support of commercial API processes for small chemical molecules Provides rapid response to operational issues and supports ongoing operations including new product introduction, process engineer, process flow diagrams and process batch record authoring Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

  • Past Projects | NUSANTARA PRIME CONSULTING

    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.

  • What's On | NUSANTARA PRIME CONSULTING

    WHAT'S ON 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.

  • QA TPM Specialist | NUSANTARA PRIME CONS

    QA TPM Specialist Responsibilities: Main contact person for the third-party manufacturing and oversee the TPM operation/process. Responsible for implementing and maintaining the effectiveness of the Quality System. Support to ensure that all quality goals are met, and all practices and procedures comply with company policies, GMP principles and applicable regulations for the quality areas. Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments. Manage TPM documents, quality agreement, FMEA, ASL and TPM scorecard/KPI. Review, evaluate and approve all major deviations and determine the need for a corrective action. Document the deviation in the Trackwise system and perform product impact analyses. Review, evaluate and approve all TPM change requests for process related, commodity, raw material, SCN, QC and facilities. Initiate global change in the Trackwise system. Provide a constant review on the manufacturing process, equipment and facilities to assure compliance with procedures, specifications, and policies. Write, review and approve annual product report/product quality report. Actively involved in Pre-campaign activities, post-campaign review (Track & trending program) Perform timely lot disposition in the SAP and LRMS/LotSmart system to meet shipment timeline and demands. Prepare CoA, CoC and release package for drug substance. Coordination of regulatory requests, including country submission, dossier review, GMP Renewal Program. About You: Bachelor Degree with at least 5 years' experiences in pharmaceutical or biotech facility preferably familiar with Quality Compliance, QA Third-party manufacturing oversight and/or QA Operations. Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility Relevant QA background from pharma or biotech environment is preferred Familiar with Health Authorities standards (e.g., FDA CFR and EU) Must be team player, meticulous, strong communication, analytical and organizational skills Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

  • Process/Project Engineer | NUSANTARA PRIME CONS

    Process/ Project Engineer Responsibilities: Experience in upstream / downstream / Central services process operation, (experience in equipment design for process equipment will be an advantage). Responsible for basic and detailed design, commissioning and qualification activities, including URS development, FAT, SAT, DQ, IQ, OQ and PQ. Review industry practices for best-in-class approach. Ensure that the appropriate Quality standards are applied consistent with best practice and internal Quality Standards and expectations. Engage with project teams to deliver the project from conceptual through implementation phase, encompassing support for a wide range of engineering and construction requirements. Coordinates with different functions like manufacturing, project engineering team, validation and quality for implementation of changes associated with the project. Work independently and/or with the project manager to complete the engineering projects within schedule, budget and quality constraints. Any other task as assigned by Supervisor/Manager. About You: Diploma/Degree in Chemical Engineering, Chemistry or equivalent with at least 5 years' experience in a process engineering role or similar role with a biologics manufacturing plan At least 2-5 years of relevant working experience in the Pharmaceutical / Biologics manufacturing industry with experience in Process Engineer In Biologics industry with understanding of cGMP requirement Should have Design experience at various stages of project (Base, Detailed design) Preferably handling the Autoclave, Glove box, CIP Skid during project phase Able to support Installation, Commissioning & Qualification activity at site. Any other task given related to Process. Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

  • Validation Engineer | NUSANTARA PRIME CONS

    Validation Engineer Responsibilities: Support equipment/system qualification and cleaning validation Develop validation lifecycle document and protocols/reports in accordance with relevan t policies, standards, procedures and guidelines, and completed in a timely fashio n Manage qualification/validation execution and lead the validation deviation investigation s encountered during qualification/validation Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities Participate in site Validation Maintenance Program Support Change Implementation on site Any other tasks as and when assigned by supervisor Support other technical changes and duties as required About You: Engineering/Science Degree or higher from recognised institution At least 5 years of experience in Equipment Qualification in the pharmaceutical/biotech industry. Experience in Critical Utilities, Cleaning validation 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.

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