Total 6 job vacancies by 3 Cubed Business Consulting Pte. Ltd.

Roles & Responsibilities

We are are looking to hire Computer Systems Validation (CSV) Engineer to join our MES team working at our client site, a pharmaceutical MNC.

Responsibilities

• Develop and implement strategies for the validation of computer systems in compliance with domestic and international regulations.
• Prepare and maintain all necessary validation documents, including validation master plans, validation plans, and risk assessments.
• Execute validation protocols and prepare validation summary reports.
• Manage change control for validated systems and perform impact assessments for changes to validated systems.
• Conduct training on CSV principles and procedures.
• Ensure compliance with all relevant regulations, including GxP, GAMP5, ERES, and Data Integrity.
• Collaborate with cross-functional teams to ensure smooth execution of validation activities.

Requirements

• Experience in a CSV role within the pharmaceutical industry is a MUST.
• Strong knowledge of GMP, GAMP5, ERES, and Data Integrity.
• Excellent communication and organizational skills.

Roles & Responsibilities

You will support the implementation and lifecycle management of the process data collection, management, and reporting infrastructure. You will implement the OSIsoft PI data historian system, production reporting systems and analytical systems to allow the start-up, commissioning, validation, and maintenance of large-scale manufacturing facilities.

Job Scope

• Collaborate with Manufacturing, Business SMEs, Validation, QA and Engineering to implement manufacturing data solutions
• Promote the increase of Site Data Historian usage to support new projects and existing value streams
• Complete extract, transform, and load ("ETL") procedures and data migration from multiple sources
• Lead projects as assigned
• Participate in the development and implementation of application/system solutions in line with S88 standards for the plant.
• Creates and maintains applications according to technical design and requirements.
• Design & Develop plan for modifications to be made to the system through working with team in development of systems architecture, specifications, controls strategies, sequence of operations through all stages.
• Provide operations support on production systems
• Use best practices on data management and visualisation to achieve our goals

Requirements

• Understanding of Osisoft PI Architecture and essential components.
• Proficient in Osisoft PI products required, SQL database or similar, or System Design and Maintenance
• Proficient in project management principles and project lifecycle phases
• Knowledge of IT infrastructure, network and database concepts
• Knowledge of cGMPs and manufacturing operations in FDA regulated facility (preferred, not essential)

Responsibilities

• Responsible for the design and delivery of DeltaV application system on site.
• Participate in the development and implementation of Automation solutions in line with S88 standards for the plant.
• Development Commissioning & Qualification protocols from C&Q Plans
• Creates and maintains applications according to technical design and requirements.
• Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with the site’s standards. Determine the processes and data flow that supports the needs of the project.
• Design & Develop plan for modifications to be made to the system through working with team in development of systems architecture, specifications, controls strategies, sequence of operations through all stages.

Requirements

• Experience in a similar role, ideally in the Pharmaceutical and/or Biotechnology industry.
• Emerson DeltaV DCS experience and DeltaV Batch experience required
• Experience in the Designing, Commissioning & Qualifications of DeltaV DCS project for GMP manufacturing site.
• Technical proficiency on controls systems including familiarity with control panels, networking, panel/field wiring and PLC control systems.
• Through understanding of Batch s88 standards (CM, EM, Phases, Recipes, Units etc)
• Familiarity with GAMP lifecycle and quality management processes employed in the pharmaceutical sector
• Ability to work well in a team environment
• Supervise and conduct system testing Factory Acceptance Test (FAT)
• Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
• Excellent communication and customer orientation skills
• Good analytical & problem-solving skills
• Ensure project Automation Strategy is followed.

Roles & Responsibilities

The last number of years has seen significant growth in the use of Manufacturing Execution Systems (MES) within the Life Science industry. With this trend set to continue, We are looking for dedicated, innovative and driven talent to join our expanding MES team.

We are are looking to hire a Senior/ Systems Programmer to join our MES team working at our client site, a pharmaceutical MNC. The selected candidate will be required to provide consultation and engineering service to the execution phase of the project. He/she will also be involved in the generation and ownership of IQ/OQ/PQ documentation and the GoLive Support.

Responsibilities

• Troubleshoot and provide solutions for MES & ERP problems in recipe execution and recipe authoring.
• Liaise with QA to provide approved change control documentation for all MES system changes.
• Design, create, write and execute to a high-quality standard, test and validation protocols, risk assessments, and system documentation.
• Design, create, write and/or make all required changes to MES & ERP Recipes, worksheets, equipment and material spec's including phase transition logic to a high-quality standard.
• Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa.
• Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access.
• Participate in MES knowledge exchanges, MES Governance meetings and manage issues, work-around and fixes identified.
• Work closely with IT regarding upgrades, patching, hardware support, security and system access and provide technical expertise in implementing upgrades and patching.
• Liaise with Global MES on required system improvements.
• Provide support to other MES system users as required to ensure business continuity.
• Participate in MES projects from initiation to ensure MES system or hardware requirements are taken into consideration.
• Ensure maintenance/replacement of MES hardware, printers, scales, scanners and bar-code labelers. Review for upgrades periodically.
• Keep other MES Team Members up to date on MES changes Documentation of all activities in line with cGMP requirements.
• Cross training within the team and training of new team members.
• Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
• Adheres to and supports all health and safety standards, procedures and policies.

Requirements

• Werum PAS-X/Aspen/Syncade, Siemens MES (Camstar / Opcenter / Simatic IT) product hands-on experience for full application configurations including interface with SAP and automation systems
• In-depth of knowledge of Pharmaceutical business process (Chemicals (W&D, Solid bulk Mfg., packaging and other unit operations), Bio Pharma processes)
• Creation of business process flow diagram
• Master Batch Record creation in Werum PAS-X
• Knowledge on Industry Standards S88 and ISA S95
• Experience working on projects in the pharmaceutical and/or biotechnology industries knowledge of GAMP lifecycle and quality management processes employed in the pharmaceutical sector Excellent communication skills and collaborative with team members and external groups

Responsibilities

• Responsible for the design and delivery of DeltaV application system on site.
• Participate in the development and implementation of Automation solutions in line with S88 standards for the plant.
• Development Commissioning & Qualification protocols from C&Q Plans
• Creates and maintains applications according to technical design and requirements.
• Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with the site’s standards. Determine the processes and data flow that supports the needs of the project.
• Design & Develop plan for modifications to be made to the system through working with team in development of systems architecture, specifications, controls strategies, sequence of operations through all stages.

Requirements

• Experience in a similar role, ideally in the Pharmaceutical and/or Biotechnology industry.
• Emerson DeltaV DCS experience and DeltaV Batch experience required
• Experience in the Designing, Commissioning & Qualifications of DeltaV DCS project for GMP manufacturing site.
• Technical proficiency on controls systems including familiarity with control panels, networking, panel/field wiring and PLC control systems.
• Through understanding of Batch s88 standards (CM, EM, Phases, Recipes, Units etc)
• Familiarity with GAMP lifecycle and quality management processes employed in the pharmaceutical sector
• Ability to work well in a team environment
• Supervise and conduct system testing Factory Acceptance Test (FAT)
• Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
• Excellent communication and customer orientation skills
• Good analytical & problem-solving skills
• Ensure project Automation Strategy is followed.

You will be responsible for the design, development, testing and support of firmware/embedded software applications for existing and next-generation Micro-controller and I/O modules in accordance with engineering best practices/processes, and in partnership with team members across the globe. You will also need to possess the working knowledge of creation and debugging of embedded/software applications. You will participate in or conduct technical reviews with peers to identify problems early in the development phases, and will also need to demonstrate the ability to consistently meet project deliverables, and to work effectively in a diverse team environment.

Requirements:

· Degree / Master in Computer Science/ Embedded Systems / Computer Engineering / Electrical Electronic Engineering with concentration in the areas of Embedded Software engineering

· Relevant experience in developing Real Time Embedded Systems.

· Experience in industrial control systems and functional safety is a great advantage

· Strong knowledge in programming language: C, Object Oriented C++

· Experience with programming 32 bits Microcontroller ( ARM or ColdFire ) and developing low level device driver.

· Experience with development in one or more of the following areas for embedded system:

· Development with RTOS, such as VxWorks, ThreadX or others

· Development of communication protocols like Ethernet/USB/WIFI and CAN/Profibus Automated unit test methodology

· Good analysis skills and proven ability to solve complex problems. Experience in using different hardware-assisted debugging tools

· Good communication and interpersonal skills and be able to work independently and as team in multi-cultural environment

· Open-minded, a willingness to experiment within acceptable boundaries and a creative mind to bring novel solutions into design and problem-solving