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Careers at NNIT SINGAPORE PTE. LTD.

NNIT Singapore Pte Ltd


Management Consultancy services for the Life Science Industry. Focus on Manufacturing Operations Management with two leading categories of serivces - Manufacturing Excellence and Compliance Excellence. 


 

NNIT SINGAPORE PTE. LTD.

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Jobs at NNIT SINGAPORE PTE. LTD.

Scientific Consultant (Principal / Manager)
NNIT SINGAPORE PTE. LTD.

$9000 to $12000 (Monthly)

Scientific Consultant


Location: Singapore based


Responsibilities:



  • Perform risk-based commissioning, qualification and validation of pharmaceutical and biopharmaceutical equipment, process and support utilities. Systems may include any or all of the following - secondary manufacturing facilities (sterile parenteral or oral dosage forms); chemical API manufacturing process; biopharmaceutical (upstream and downstream) manufacturing process; CIP; SIP; clean steam; purified water; WFI system; laboratory equipment (e.g., GC-MS, HPLC).

  • Develop risk assessment, system impact assessments, validation plans / strategies, protocols and reports that support the qualification and validation of process and utility systems.

  • Develop moderate to highly complex protocols for validation projects using a risk-based approach that meets regulatory requirements and industry best practices.

  • Review, analyse, interpret, and summarize system and process performance data of executed activities for report and presentation to management.

  • Investigate deviations, write investigation reports and create summary reports.

  • Promote cGMP and regulatory compliance into assigned projects per latest regulatory requirements and industry practices.

  • Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.


Professional Skills and Experience:



  • At least Bachelor’s degree in technical discipline such as Engineering or Science or with experience relevant to the Job Description. Graduates of related discipline may also apply.

  • 2+ years (Analyst) or 4+ years (Consultant) experience in validation, quality systems, quality operations, manufacturing, engineering, technology transfer or any combination thereof in pharmaceutical industry.

  • Highly preferred to have experience in multiple GMP validation discipline (such as CIP, SIP, process, utility, equipment, automation, computer system, serialization), preferably with advanced technical knowledge in one or more discipline.

  • Good understanding of risk-based approach (FMEA, PHA, etc) per ICH Q9.

  • Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, commissioning, I/O/PQ protocols, etc) guidelines, international regulatory requirements and standards and other industry practices.

  • Experience interacting with or creating material for management and regulatory agencies (preferably).

  • Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective/preventive actions.


Offering:



  • Consulting roles for international healthcare clients in strategically relevant projects

  • Work in a professional consultancy environment within a highly motivated team

  • Opportunity to take on responsibility and to help shape our organization

  • Excellent career development and growth opportunities in a growing premier consulting organization

  • Structured training program and peer mentoring system to support competence and personal growth

a year ago
Automation Engineer
NNIT SINGAPORE PTE. LTD.

$5000 to $8500 (Monthly)

Automation Engineer


Location: Singapore based


Role description:


This role is responsible to support the deployment of Automation projects for international Pharma and Life Science clients. The various automation projects will include projects relating to  ERP (Enterprise Resource Planning Systems), MES (Manufacturing Execution System), Data Historian OSI PI, PLC / SCADA, and DCS (Distributed Control Systems such as Emerson DeltaV, Siemens Simatic PCS This position may also provide daily operational support, administration and management for these systems, as well as system enhancements and upgrades.


In this role the Automation Engineer will work in accordance to the client’s Computer Systems Validation policies and procedures to ensure that all projects are implemented in a quality manner, in compliance with appropriate regulations.


Responsibilities include:



  • Manage automation and/or      computer system validation (CSV) projects in regulated environments.

  • Generate, review and approve validation      documents.

  • Knowledgeable in Control Systems/Process      Automation Software, HMI (Human Machine Inteface)/SCADA (Supervisory      Controls and Data Acquisition Software), Safety Instrumented Systems,      Plant Asset Management (PAM), Plant Information Management Systems (PIMS),      OLE for Process Control (OPC), EPC Tools, Field Communicator Handled, Field Instruments Handled.

  • Specialist in DeltaV I/O and      Communication Infrastructure Handheld consoles, Process Instruments,      Calibration, Pneumatic/Hydraulics, Fieldbus/Hart, Delta-V Multi-Node      systems and Network environment.

  • Manage DeltaV system      Installation, Configuration, Testing and Commissioning.

  • Perform Advance Services such      as System Upgrades, Preventive Maintenance, Cybersecurity Assessment and      Implementation, Patch Management, Backup and Recovery, Preventive      Maintenance, and Troubleshooting for DeltaV Systems


Professional Skills and Experience:



  • Degree (or similar) in IT,      Engineering or Industrial Instrumentation and Process Controls.

  • 4+ years’ relevant working experience      working

  • Experience working in a GxP      environment is a plus.

  • Excellent written and verbal      communication skills.

  • Strong organizational and      project management skills.

  • Familiar with compliance      requirements (FDA, EMA, GxP, GAMP 5, 21 CFR Part 11, PICs, etc.).

  • Experience in implementing      any of the following systems will be an added advantage: ERP (Enterprise      Resource Planning Systems), MES (Manufacturing Execution System),      Electronic Batch Records, Information Management Systems, Data Historian,      PLC / SCADA, DCS (Distributed Control Systems)


Offering:



  • Consulting roles for      international Pharma and Life Science clients in strategically relevant      projects.

  • Work in a professional      consultancy environment within a highly motivated team.

  • The opportunity to take on      responsibility and to help shape our organization.

  • Excellent career development      and growth opportunities.

2 years ago
MS&T Consultant (Junior Consultant)
NNIT SINGAPORE PTE. LTD.

$3500 to $5000 (Monthly)

MS&T Consultant (Junior Consultant)


Responsibilities:


· Perform risk-based commissioning, qualification and validation of pharmaceutical and biopharmaceutical equipment, utilities and process.


· Executed / develop validation protocols using a risk-based approach that meets regulatory requirements and industry best practices.


· Develop risk assessment, system impact assessments, protocols and reports that support the qualification and validation of process and utility systems.


· Be part of the team that review, analyse, interpret, and summarize system and process performance data of executed activities for report and presentation to management.


· Be part of the team that investigate deviations, write investigation reports and create summary reports.


· Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.


Professional Skills and Experience:


· At least Bachelor’s degree in technical discipline such as Engineering or Science or with experience relevant to the Job Description. Graduates of related discipline may also apply.


· 2 years or more years of experience in validation, quality systems, quality operations, manufacturing, engineering, technology transfer or any combination thereof in pharmaceutical industry.


· Fresh graduate with internship experience in pharmaceutical industry will be considered.


· Preferred to have experience in one or more CQV discipline (such as process equipment, laboratory equipment, cleaning, sterilization).


· Familiarity of ICH Q7, Q8 and ICH Q9.


· Preferably with good knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.


Offering:


· Consulting roles for international healthcare clients in strategically relevant projects.


· Work in a professional consultancy environment within a highly motivated team.


· Opportunity to take on responsibility and to help shape our organization.


· Excellent career development and growth opportunities in a growing premier consulting organization.


· Structured training program and peer mentoring system to support competence and personal growth.

2 years ago
MS&T Consultant (Principal/Manager)
NNIT SINGAPORE PTE. LTD.

$8000 to $14000 (Monthly)

MS&T Consultant (Principal/Manager)


Responsibilities:


· Perform risk-based commissioning, qualification and validation of pharmaceutical and biopharmaceutical equipment, utilities and process. Systems may include any or all of the following - secondary manufacturing facilities (sterile parenteral or oral dosage forms); chemical API manufacturing process; biopharmaceutical (upstream and downstream) manufacturing process; CIP; SIP; clean steam; HVAC; purified water; WFI system; laboratory equipment (e.g., GC-MS, HPLC).


· Develop risk assessment, system impact assessments, validation plans / strategies, protocols and reports that support the qualification and validation of process and utility systems.


· Develop moderate to highly complex validation protocols using a risk-based approach that meets regulatory requirements and industry best practices.


· Review, analyse, interpret, and summarize system and process performance data of executed activities for report and presentation to management.


· Investigate deviations, write investigation reports and create summary reports.


· Promote cGMP and regulatory compliance into assigned projects per latest regulatory requirements and industry practices.


· Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.


Professional Skills and Experience:


· At least Bachelor’s degree in technical discipline such as Engineering or Science or with experience relevant to the Job Description. Graduates of related discipline may also apply.


· 12 years or more years of experience in qualification and validation, quality systems, quality operations, manufacturing, engineering, technology transfer, method validation or any combination thereof in pharmaceutical industry.


· Highly preferred to have experience in multiple GMP validation discipline (such as CIP, SIP, process, utility, equipment, automation, computer system, serialization), preferably with advanced technical knowledge in one or more discipline.


· Good understanding of ICH Q7, Q8, ICH Q9 and other regulatory requirements.


· Knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.


· Experience interacting with or creating material for management and regulatory agencies (preferably).


· Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective/preventive actions.


Offering:


· Consulting roles for international healthcare clients in strategically relevant projects.


· Work in a professional consultancy environment within a highly motivated team.


· Opportunity to take on responsibility and to help shape our organization.


· Excellent career development and growth opportunities in a growing premier consulting organization.


· Structured training program and peer mentoring system to support competence and personal growth.

2 years ago
Systems Engineer / Business Analyst
NNIT SINGAPORE PTE. LTD.

$5000 to $8000 (Monthly)

Systems Engineer / Business Analyst


Location: Singapore based


Role description:


The role is responsible in supporting the deployment, maintenance or service delivery of systems preferably in regulated environment. He/she should have experience in project implentations with exposures to manufacturing automation system such as MES(manufacturing execution system) such as Emerson, Syncade, DeltaV, OSI PI, PASX, PLC/SCADA, SQL, Siemens Simatic PCS 7, DCS(distributed control systems) or laboratory practices with LIMS (laboratory information management System) and CDS (chromatography data system) etc. This position may include operational support, system administration, enhancements and upgrades.


The System Engineer/Business Analyst is required to work in accordance to systems procedural control, policy governance and project framework to ensure projects are implemented in Quality and controlled manner with compliance to appropriate regulations standards.


Responsibilities include:



  • Participated in project      implementations and delivery in regulated environments.

  • Ability to generate, review      and approve CSV (computer system validation) documentations.

  • Support project management      activities, identify and pro-actively manage project risks.

  • Ensure      operational compliance to Regulatory Regulations, Quality and Best      Practice and governance standards.

  • Analyse business needs,      propose solutions and assist in user’s requirements gathering.


· Perform technical system development, technical configurations and system testing where appropriate.


Professional Skills and Experience:



  • Degree (or similar) in IT,      Engineering or Science.

  • 2+ years’ experience working      in GxPs environment.

  • 2+ years’ experience working on      CSV projects.

  • Excellent written and verbal      communication skills.

  • Strong organizational and      project management skills.

  • Familiar with compliance      requirements (FDA, EMA, GxP, GAMP 5, 21 CFR Part 11, PICs, etc.).

  • Experience in implementing      any of the following systems will be an added advantage: ERP (Enterprise      Resource Planning Systems), MES (Manufacturing Execution System), WERUM      PASX, PI, SQL, Electronic Batch Records, Data Historian, PLC/ SCADA, LIMS      (Laboratory Information Management System), DCS (Distributed Control      Systems) and CDS (Chromatography Data System)


Offering:



  • Consultation roles for      international Pharma and Life Science clients in strategically relevant      projects.

  • Work in a professional      consultancy environment within highly motivated teams.

  • The opportunity to take on      responsibility and to help shape our organization.

  • Excellent career development      and personal growth opportunities.

  • Ability for 10% business      travel domestically

2 years ago
IT Analyst
NNIT SINGAPORE PTE. LTD.

$4000 to $6000 (Monthly)

IT Analyst


Location: Singapore based


Role description:


This role is responsible to support the deployment of IT projects and systems for international Pharma and Life Science clients. The various IT projects and systems include ERP (Enterprise Resource Planning Systems), MES (Manufacturing Execution System), Data Historian, PLC / SCADA, DCS (Distributed Control Systems), LIMS (Laboratory Information Management System) and CDS (Chromatography Data System). This position may also provide daily operational support, administration, and management for these systems, as well as system enhancements and upgrades.


In this role, the IT Analyst may be responsible for performing the analysis and design associated with new requirement. The IT Analyst will work in accordance to the client’s Computer Systems Validation policies and procedures to ensure that all projects are implemented in a quality manner, in compliance with appropriate regulations.


Responsibilities include:



  • Manage/support project quality for IT projects in      regulated environments.

  • Support project management activities, identify and      pro-actively manage project risks.

  • Write quality/validation plans, project documentation      and procedures.

  • Ensure full compliance to regulatory, quality, and best      practice standards.

  • Provide strategic consulting for Computer System      Validation, Information Security and Data Privacy.

  • Conduct and facilitate IT Audits and IT Vendor Reviews.

  • Analyse business needs, propose solutions and assist in      users requirements gathering.


· Create IT functional and technical specifications.


· Perform technical system development, technical configurations and system testing, where appropriate.


Offering:



  • Consulting roles for international Pharma and Life      Science clients in strategically relevant projects.

  • Work in a professional consultancy environment within a      highly motivated team.

  • The opportunity to take on responsibility and to help      shape our organization.

  • Excellent career development and growth opportunities.


Professional Skills and Experience:



  • Degree (or similar) in IT, Engineering or Science.

  • 2+ years’ experience working in IT related areas.

  • 2+ years’ experience working in GxP environment.

  • Excellent written and verbal communication skills.

  • Strong organizational and project management skills.

  • Ability to communicate quality and risk-related      concepts to technical and non-technical audiences.

  • Familiar with compliance requirements (SOX, FDA, GxP,      21 CFR Part 11, COBIT, Records Management, BCM / Disaster Recovery, etc.).

  • Experience in implementing any ERP (Enterprise Resource      Planning Systems), MES (Manufacturing Execution System), Electronic Batch Records,      Information Management Systems, Data Historian, PLC / SCADA, DCS      (Distributed Control Systems), LIMS (Laboratory Information Management      System) and CDS (Chromatography Data System).

2 years ago
Scientific Consultant (Principal / Manager)
NNIT SINGAPORE PTE. LTD.

$9000 to $12000 (Monthly)

Scientific Consultant


Location: Singapore based


Responsibilities:



  • Perform risk-based commissioning,      qualification and validation of pharmaceutical and biopharmaceutical      equipment, process and support utilities. Systems may include any or all      of the following - secondary manufacturing facilities (sterile parenteral      or oral dosage forms); chemical API manufacturing process;      biopharmaceutical (upstream and downstream) manufacturing process; CIP;      SIP; clean steam; purified water; WFI system; laboratory equipment (e.g.,      GC-MS, HPLC).

  • Develop risk assessment, system impact      assessments, validation plans / strategies, protocols and reports that      support the qualification and validation of process and utility systems.

  • Develop moderate to highly complex      protocols for validation projects using a risk-based approach that meets      regulatory requirements and industry best practices.

  • Review, analyse, interpret, and summarize system      and process performance data of executed activities for report and      presentation to management.

  • Investigate deviations, write      investigation reports and create summary reports.

  • Promote cGMP and regulatory compliance      into assigned projects per latest regulatory requirements and industry      practices.

  • Exercise good judgment within generally      defined practices and policies in selecting methods and techniques for obtaining      solutions.


Professional Skills and Experience:



  • At least Bachelor’s degree in technical      discipline such as Engineering or Science or with experience relevant to      the Job Description. Graduates of related discipline may also apply.

  • 2+ years (Analyst) or 4+ years      (Consultant) experience in validation, quality systems, quality      operations, manufacturing, engineering, technology transfer or any      combination thereof in pharmaceutical industry.

  • Highly preferred to have experience in      multiple GMP validation discipline (such as CIP, SIP, process, utility, equipment,      automation, computer system, serialization), preferably with advanced      technical knowledge in one or more discipline.

  • Good understanding of risk-based approach      (FMEA, PHA, etc) per ICH Q9.

  • Knowledge of Validation Lifecycle approach      (URS, FRS, FAT/SAT, commissioning, I/O/PQ protocols, etc) guidelines,      international regulatory requirements and standards and other industry      practices.

  • Experience interacting with or creating      material for management and regulatory agencies (preferably).

  • Experience with investigations into      manufacturing deviations and determination of product impact potential,      root cause and corrective/preventive actions.


Offering:



  • Consulting roles for international      healthcare clients in strategically relevant projects

  • Work in a professional consultancy      environment within a highly motivated team

  • Opportunity to take on responsibility and      to help shape our organization

  • Excellent career development and growth      opportunities in a growing premier consulting organization

  • Structured training program and peer      mentoring system to support competence and personal growth

2 years ago
Advanced / Senior Consultant for Manufacturing Execution System (MES)
NNIT SINGAPORE PTE. LTD.

$8000 to $14000 (Monthly)

Advanced / Senior Consultant for Manufacturing Execution System (MES)


Location: Singapore based


Role description:


This role is responsible to support the deployment of MES-ERP Application for Werum PAS-X catering to the Life Science Pharmaceutical domain of Batch Manufacturing.  Instrumental in designing, building, and implementation with GxP compliant process with 21 CFR part 11 and drive global manufacturing process standardization according to ISA 95 and ISA 88.


Responsibilities include:



  • Computerize System Validation for Manufacturing      Execution System

  • Lead MES implementation, Recipe Authoring and System      Configuration

  • Lead project management activities, identify and      pro-actively manage project risks.

  • Provide advice on validation      strategy, based upon GAMP 5 risk-based approach

  • Ensure full      compliance to regulatory, quality, and best practice standards.

  • Analyse business needs, propose solutions and assist      in user’s requirements gathering.


Professional Skills and Experience:



  • 8+ years of relevant working experience.

  • Degree (or similar) in IT, Engineering or Science.

  • Computerized System Validation and IT Systems Implementation      Expert

  • Expert in Werum PAS-X

  • Expert in      MES System Validation

  • Expert in      Recipe Authoring and Configuration Management

  • Excellent documentation, communication, and      interpersonal skills, with an ability to liaise effectively and      professionally with individuals at all levels.

  • Strong organizational and project management      skills.

  • Familiar with compliance requirements (FDA, EMA,      GxP, GAMP 5, 21 CFR Part 11, PICs, etc.).


Offering:



  • Consulting roles for international Pharma and Life      Science clients in strategically relevant projects.

  • Work in a professional consultancy environment      within a highly motivated team.

  • The opportunity to take on responsibility and to      help shape our organization.

  • Excellent career development and growth      opportunities.

2 years ago
MS&T Consultant (Consultant / Advanced Consultant)
NNIT SINGAPORE PTE. LTD.

$5000 to $8000 (Monthly)

MS&T Consultant (Consultant / Advanced Consultant)


Responsibilities:


· Perform risk-based commissioning, qualification and validation of pharmaceutical and biopharmaceutical equipment, utilities and process.


· Develop risk assessment, system impact assessments, protocols and reports that support the qualification and validation of process and utility systems.


· Develop validation protocols using a risk-based approach that meets regulatory requirements and industry best practices.


· Review, analyse, interpret, and summarize system and process performance data of executed activities for report and presentation to management.


· Investigate deviations, write investigation reports and create summary reports.


· Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.


Professional Skills and Experience:


· At least Bachelor’s degree in technical discipline such as Engineering or Science or with experience relevant to the Job Description. Graduates of related discipline may also apply.


· 6 years or more years of experience in validation, quality systems, quality operations, manufacturing, engineering, technology transfer or any combination thereof in pharmaceutical industry.


· Preferred to have experience in multiple CQV discipline (such as CIP, SIP, process, utility, equipment, automation, computer system), preferably with advanced technical knowledge in one or more discipline.


· Good understanding of ICH Q7, Q8, ICH Q9 and other regulatory requirements.


· Knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.


· Experience interacting with or creating material for management and regulatory agencies (preferably).


· Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective/preventive actions.


Offering:


· Consulting roles for international healthcare clients in strategically relevant projects.


· Work in a professional consultancy environment within a highly motivated team.


· Opportunity to take on responsibility and to help shape our organization.


· Excellent career development and growth opportunities in a growing premier consulting organization.


· Structured training program and peer mentoring system to support competence and personal growth.

2 years ago