Current jobs related to Csv Engineer - Singapore - COALESCE MANAGEMENT CONSULTING PTE. LIMITED

  • CSV Engineer

    11 hours ago

    Singapore NO DEVIATION PTE. LTD. Full time

    Roles & ResponsibilitiesNo Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.We...

  • CSV Engineer

    11 hours ago

    Singapore AMARIS CONSULTING PTE. LTD. Full time

    Roles & ResponsibilitiesJob Description: Develop and implement Computer System Validation (CSV) protocols and procedures in accordance with industry standards for DeltaV. Conduct risk assessments and validate computer systems, software, and automated processes to ensure compliance. Collaborate with cross-functional teams to gather requirements and define...

  • Automation Systems Specialist

    2 weeks ago

    Singapore ALWAYSHIRED PTE. LTD. Full time

    Job Title: MES Automation EngineerAt AlwaysHired Pte Ltd, we are seeking a highly skilled MES Automation Engineer to join our team.Job Summary:We are looking for a talented engineer with expertise in Computerized System Validation (CSV) and Computerized System Assurance (CSA) to provide consulting services to pharmaceutical and medical device manufacturing...

  • MES Automation Engineer

    2 weeks ago

    Singapore ALWAYSHIRED PTE. LTD. Full time

    Roles & ResponsibilitiesResponsibilities: Provide Computerized System Validation (CSV) / Computerized System Assurance (CSA) consulting services for pharmaceutical and medical device Manufacturing company. Manage SDLC (system design life cycle) including risk, deviation and change managements (e.g., conduct risk impact or functional assessment(s)) Ensure...

  • Automation Systems Engineer

    2 weeks ago

    Singapore B & P COEFFICIENT PTE. LTD. Full time

    Job DescriptionB & P COEFFICIENT PTE. LTD. is seeking a highly skilled Automation Systems Engineer to join our team. As an Automation Systems Engineer, you will be responsible for designing and developing system and network architecture, collaborating with cross-functional teams, and ensuring compliance with CSV and QA standards.Key...

  • Automation Systems Specialist

    1 week ago

    Singapore ALWAYSHIRED PTE. LTD. Full time

    Job Title: MES Automation EngineerAt AlwaysHired Pte Ltd, we are seeking a highly skilled MES Automation Engineer to join our team.Job Summary:We are looking for a talented engineer to provide Computerized System Validation (CSV) and Computerized System Assurance (CSA) consulting services for pharmaceutical and medical device manufacturing companies. The...

  • Data Engineer

    2 weeks ago

    Singapore PERSOLKELLY SINGAPORE PTE. LTD. Full time

    About the RolePersolKelly Singapore Pte. Ltd. is seeking a highly skilled Data Engineer to join our team. As a Data Engineer, you will be responsible for designing, developing, and maintaining complex data systems and solutions using Python and Big Query.Key ResponsibilitiesDevelop and maintain highly complex scripts using Python and Big Query.Design and...

  • Automation Engineer

    2 weeks ago

    Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

    Key ResponsibilitiesPES is a leading international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors.We are currently seeking a skilled Delta V Automation Engineer – Pharma to join our team in Singapore. The...

  • Automation Engineer

    2 weeks ago

    Singapore CUTE SOLUTIONS & SERVICES PTE. LTD. Full time

    Roles & ResponsibilitiesResponsibility: Responsible for leading Pharma and Biopharma projects using DeltaV System or PLC Siemens with batch design (CM, EM, Phase, Recipe, etc) Responsible for design & managing system integrator and ensure they follow company standards and approved guidelines Responsible for managing internal stakeholders and coordination...

  • Process Engineer

    2 weeks ago

    Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

    Roles & ResponsibilitiesPosition: Process EngineerWe are Coalesce Management Consulting - a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists.We are currently expanding our team and are looking for a Process...

  • Automation Project Manager

    2 weeks ago

    Singapore KINETICS PROCESS CONSULTING PTE. LTD. Full time

    Project Manager - Automation and EngineeringKINETICS PROCESS CONSULTING PTE. LTD. is seeking a highly skilled Project Manager to lead our automation and engineering projects.Key Responsibilities:Manage project stakeholder groups and coordinate automation project resources to ensure timely and successful project deliveryMonitor, report and escalate project...

  • Quality Engineer

    11 hours ago

    Singapore CIBA VISION ASIAN MANUFACTURING AND LOGISTICS PTE. LTD. Full time

    Roles & ResponsibilitiesAt Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in...

  • Senior Automation Project Manager

    2 weeks ago

    Singapore KINETICS PROCESS CONSULTING PTE. LTD. Full time

    Roles & ResponsibilitiesResponsibilities: Manage project stakeholder groups and coordinate automation project resources to ensure timely and successful project delivery Monitor, report and escalate project issues, risks, changes and progress to project stakeholders, sponsors, and line management Support tender process and supplier/contractor selection and...

  • Automation Expert

    2 weeks ago

    Singapore NO DEVIATION PTE. LTD. Full time

    Senior Automation EngineerNo Deviation PTE. LTD. is a leading provider of patient-centric solutions for the pharmaceutical industry. We are seeking a highly skilled Senior Automation Engineer to lead our Pharma and Biopharma projects using DeltaV System with batch design.Key Responsibilities:Lead Pharma and Biopharma projects using DeltaV System with batch...

  • Senior Automation Specialist

    7 days ago

    Singapore NO DEVIATION PTE. LTD. Full time

    Senior Automation EngineerNo Deviation PTE. LTD. is a leading provider of patient-centric solutions for the pharmaceutical industry. We are seeking a highly skilled Senior Automation Engineer to join our team.Key Responsibilities:Lead Pharma and Biopharma projects using DeltaV System with batch design (CM, EM, Phase, Recipe, etc)Design and manage DeltaV...

  • Senior Automation Engineer

    2 weeks ago

    Singapore NO DEVIATION PTE. LTD. Full time

    Roles & ResponsibilitiesNo Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.We...

  • Digital Transformation Consultant

    2 weeks ago

    Singapore NNIT SINGAPORE PTE. LTD. Full time

    About the RoleWe are seeking a highly skilled Digital Transformation Consultant to join our team at NNIT Singapore PTE. LTD. as a key member of our Life Science Manufacturing domain.The successful candidate will have a strong background in IT Infrastructure and Manufacturing Systems, with a proven track record of delivering Quality Assurance and Regulatory...

  • ETL Developer

    2 weeks ago

    Singapore NITYO 3P SOLUTIONS PTE. LTD. Full time

    Roles & ResponsibilitiesKey Responsibilities: Ability to working in different domains: Banking, Telecom and Healthcare. Good knowledge on banking domain especially collections process of the bank. Strong experience in entire life cycle of data warehouse projects right from the beginning of requirement gathering to deployment in production. Interacted with...

  • Associate, Infrastructure Developer, Technology Services, Technology

    4 months ago

    Singapore DBS Bank Full time

    Business Function Group Technology and Operations (T&O) enables and empowers the bank with an efficient, nimble and resilient infrastructure through a strategic focus on productivity, quality & control, technology, people capability and innovation. In Group T&O, we manage the majority of the Bank\'s operational processes and inspire to delight our business...

  • AVP, Web Application Developer, Group Infrastructure and Cloud, Technology

    4 weeks ago

    Singapore DBS Bank Limited Full time

    Business Function Group Technology and Operations (T&O) enables and empowers the bank with an efficient, nimble and resilient infrastructure through a strategic focus on productivity, quality & control, technology, people capability and innovation. In Group T&O, we manage the majority of the Bank's operational processes and inspire to delight our business...

Csv Engineer

3 months ago

Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

Position:
CSV Engineer
At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists.


We are currently expanding our team and are looking for a
CSV Engineer to support projects on site with a client.


In summary, you will be responsible for managing all computer systems validation activities including, but not limited to, drafting, reviewing, and approving all CSV-related activities, as well as conducting deviation investigations, and working alongside the teams that provide QA oversight to ensure consistent compliance of cGMP standards.


Key Responsibilities:

  • Establish Cleaning Validation master plans and execution plans for GMP Equipment comprising of both API and Biologics manufacturing facilities.
  • Collaborate with validation and tech support teams in other sites to ensure a consistent and cohesive approach to Cleaning Validations.
  • Conduct deviation investigations, identification and completion of corrective and preventative actions.
  • Supervise contractors, engineers and provide day to day support to operations including, modifications and changes to processes and equipment, and troubleshooting activities.
  • Analyse business trends, and propose solutions to issues that can potentially impact the validation status of GMP equipment.

Requirements:

  • Degree in Science or Engineering or any other related qualifications.
  • Familiar with government code of practice, regulations, current Good Manufacturing Practice (cGMP), Good Documentation Practice (GDP).
  • At least 38 years of experience in to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.

What's In It for You?

  • Exposure to the major Pharmaceutical Companies in the industry.
  • Annual leave benefits.
  • Full Health coverage and benefits.
  • Training and Development allowance.
**What's Next?