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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.

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

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.

Quality System Specialist Responsibilities: Coordinate with suppliers and verify supplier quality standards are in accordance to the requirements Track and qualify or disqualify suppliers according to standards Liaise with suppliers or support the senior supplier qual specialist to support documentation compilation and GMP/GDP review per procedural requirements Monitor supplier quality performance by tracking product defects, delivery failures and other recorded incidents involving the supplier's failure to meet requirements Support document centre activities Maintain accurate quality records, certifications and database records Compiles Supplier Quality Reports for Management Support regular and routine supplier quality audits to ensure compliance with regulatory standards, waste elimination and continuous improvement Any other task as assigned by Supervisor/Manager Based in Tuas About You: Bachelor Degree with at least 1-2 years' experiences in pharma or biotech facility preferably familiar with biopharma QA Operations. Possess GMP systems knowledge with Supplier Quality Management concept Knowledge of quality management system, supplier quality management, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility Must be team player, meticulous, strong analytical and organizational skills Enthusiastic, interested and committed to support Quality systems processes and potential participation in new product introduction activities Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

CQV Engineer Responsibilities: Develop, review and/or approve validation lifecycle documents and protocols/reports and deliverables in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion. Take lead and review project design documents (P&IDs, PFDs, URS etc.) Define user requirements and create SOPs or documentation related to the validation activities Manage qualification execution and lead validation deviation investigation encountered in qualification. Create and review validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification activities Participate in site Validation Maintenance Program. Write execution related deviations and change requests Support change implementation on site. Manage Change Control to update SOPs, Risk Assessment, Requirement Traceability Matrix and/or Automation System Life cycle documentation as needed Perform validation documentation and/ or support validation documentation in accordance to the division procedures Regular preview of pending activities to maintain validation status with validation lead, supervisor or manager Ensure validation execution meets compliance, validation standards and cGMP requirements Any other task as assigned by Supervisor/Manager About You: Diploma/Degree in Engineering or Science Disciplines with 3 to 5 years experience in Pharmaceutical Industry Proven track record in Equipment Qualification for HVAC and Utilities Validation (IQ/OQ/PQ/CPV) In-depth knowledge on cGMP, GDP and ASTM E2500 Proactive and self-motivated Demonstrated proficiency of written and verbal communication skills in English (including technical writing and presentations) Effective Project Management, leadership, communication and interpersonal skills Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

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.

Validation Engineer Responsibilities: Support equipment/system qualification and cleaning validation Develop cleaning validation lifecycle document and protocols/reports in accordance with relevant policies, standards, procedures and guidelines, and completed in a timely fashion Manage qualification/validation execution and lead the validation deviation investigations encountered during qualification/validation Collaborate with multi functions to arrange, plan and ensure smooth running of the qualification/validation activities Support Change Implementation on site Any other tasks as and when assigned by supervisor Support other technical changes and duties as required About You: Diploma/Bachelor/Master/Doctoral Degree in Engineering/Science. At least 4 to 6 years qualification/validation experience. Cleaning validation experiences in Biologics and/API process. Based in Tuas Submit your resume to recruitment@nusaprime.com. Only shortlisted candidates will be contacted.

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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.