Search Results

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.

OUR STORY OUR STORY NUSANTARA PRIME CONSULTING was founded in 2019 with a single purpose to be the most successful and ground-breaking consulting agency; providing best-in-class services to support our customers in producing quality healthcare timely and economically . We're committed to providing companies and individuals with quality products and innovations in an industry that is constantly changing. The birth of the NUSANTARA brand: NUSA meaning “island ”, and ANTARA meaning “interconnection ” With a holistic thought process, we are dedicated to partnering with our clients on end to end solution support delivering life-saving therapeutic drugs to the patients OUR VISION To be the most successful and ground-breaking consulting agency; providing best-in-class products and services to support our customers in producing quality healthcare timely and economically. OUR MISSION With a holistic thought process, we are dedicated to partnering with our clients on end-to-end solution support delivering life-saving therapeutic drugs to the patients.

ADD A TESTIMONIAL How Did We Do? Would you recommend us to your friends? Yes No Thanks for submitting! Submit Testimonial Form: Testimonial Form

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!

HR & Admin Assistant Responsibilities: Perform daily administrative and assist human resources tasks within the department Assist in recruitment activities including job advertisement posting and downloading of resumes from job portals Assist in the onboarding process for new hires including preparation of Employment Agreement, onboarding document, conduct orientation, employee data input into HR system and etc Assist in the offboarding process for resign staff including preparation of letters, exit interview and exit clearance Monitor and assist in work pass administration for new application, renewal and cancellation Grant submission on Government portal Maintain, update and ensure proper documentation filing for all HR and admin related document and files Provide secretarial support to the CEO Provide office administration support including but not limited to procurement of office and pantry supplies, office equipment maintenance and etc Provide administrative support to the Management and sales team including preparing of sales related document, travel booking and etc Act as the point of contact within company for any administrative or basic HR-related inquiry Assist in scheduling meetings, conference calls, corporate/team functions or organising company events Assist in the preparation or update of company organisation chart, policies and process flows Assist in the preparation of company newsletters and festive greeting poster Assist in ad-hoc HR projects and any other assigned Admin duties About You: Possess Diploma / GCE 'A' Levels Minimum 1 to 2 years of relevant experience in HR or office administration support Have a good sense of urgency, meticulous and demonstrate initiatives with good follow-up skills Working knowledge of local labour legislation Comfortable interacting with people at all levels Able to work independently, multi-task and a good team player Able to work in fast pace environment Proficient in Microsoft office applications is a must Must have a good attitude of motivation Hybrid office and work from home arrangement * Internship/Part-time options available Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

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.

4 Key Aspects to Problem-Solving and Decision-Making Assessing the SITUATION Identify the concerns Setting priorities Develop an action and resource plan Describe the problem Identify and evaluate possible cause Confirming the root cause Analyzing the PROBLEM DECISION-MAKING Clear Objective Identify options Assess risks Resolution Identify potential problems Identify probable causes Identify countermeasures Prepare and set triggers for contingency action Prepare CONTINGENCY plan Roger Ho | Head of Product Management and Training Services

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.

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.

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.