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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.

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.

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.

Quality-Automation Liaison Responsibilities: Initiate Document Tracking once finished draft received from Automation Engineer. Organize and trace document lifecycle, on AttachePro. Liaise with Quality Assurance, Quality Compliance, Computerised System Validation for Automation Documents. Learn manufacturing process and respond to test event deviations, keep track of repetitive responses for re- use and create where required. Support automation projects (Delta V, PLC/SCADA and OSI PI) in accordance with policies and procedures. Obtain approval for system installation, configuration, testing and commissioning documents. Manage Computer System Validation Lifecycle from design to execution phases. Once more experience is gained, ability to evaluate change requests and assist in drafting. Any other task as assigned by Supervisor/Manager. About You: Industrial, Pharmaceutical, Chemical or relevant Engineering degree. Basic knowledge of Automation System Architecture is required, exposure to Emerson DeltaV is a plus but not required, training will be provided. Knowledge of validation lifecycle, compliance requirements (GAMP 5, 21 CFR Part 11 and regulatory requirements), and current Good Manufacturing Practices (cGMP) Adaptable, proactive, able to build relationship with other professionals. Must be team player, curious with strong analytical and organizational skills. Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

The Full Story About This is your About Page. It's a great opportunity to give a full background on who you are, what you do and what your website has to offer. Double click on the text box to start editing your content and make sure to add all the relevant details you want to share with site visitors. Mission This is a Paragraph. Click on "Edit Text" or double click on the text box to start editing the content and make sure to add any relevant details or information that you want to share with your visitors. Vision This is a Paragraph. Click on "Edit Text" or double click on the text box to start editing the content and make sure to add any relevant details or information that you want to share with your visitors.

MEET OUR CLIENTS We’re fortunate to work with some of the best clients around, and would love for you to become a partner. Our team includes experts from many fields who are ready to help develop and grow your business. From ideation to execution, we have vast experience throughout.

CSV Engineer Responsibilities: Manage Computer System Validation Lifecycle from design to execution phases, Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols. Work with QA and stakeholders to develop the CSV strategy Responsible for providing CSV documents and protocols, performing execution for automated equipment and/or control systems, and closure of executed protocols. Responsible for test case execution, deviation handling and drafting of system SOPs. Any other task as assigned by Supervisor/Manager. About You: Bachelor of Science/Engineering or higher in a scientific or related engineering discipline At least 4 – 8 years of experience in validation or computerized system validation Able to initiate and drive validation discussion. Must be a team player, curious with strong analytical and organizational skills. Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

Quality Operation Specialist 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.

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.

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.