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- Associate CSV Engineer | NUSANTARA PRIME CONS
Associate 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. Responsible for preparation of CSV documents and protocols, perform execution for automated equipment and/or control systems, and closure of executed protocols. Perform troubleshooting during test execution. Responsible for execution of thermal mapping activities. Write execution related deviations and change requests. Any other task as assigned by Supervisor/Manager. About You: Diploma / Bachelor Degree in Computer Science/IT, Engineering or Industrial Instrumentation and Process controls. Min. 1 year' experiences in CSV preferably in biotech facility. Fresh graduates welcome to apply. Good knowledge of validation lifecycle, compliance requirements (GAMP 5, 21 CFR Part 11 and regulatory requirements), and current Good Manufacturing Practices (cGMP) Familiar with Health Authorities standards (e.g., FDA CFR and EU) Knowledge of thermal mapping validation and usage of data logger is a plus. Demonstrated proficiency of writte n and verbal communication skills with ability to communicate and collaborate effectively with cross-functional teams Must be team player, curious with strong analytical and organizational skills Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.
- About Us | NUSANTARA PRIME CONS
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.
- Current Projects | NUSANTARA PRIME CONSULTING
CURRENT 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.
- 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 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 Specialist Candidate is responsible for leading the development of operational protocols, monitor, optimize, and troubleshoot issues related to either fermentation/cell culture or protein purification processes and unit operations 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. 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. Validation Engineer Support equipment qualification, system qualification, and cleaning validation. Document Control Specialist This role is responsible to manage document accuracy, updated Master list and distribution matrix, maintain ISO standards, and projects documents. Laboratory Analyst T he 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. 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.