Change Manager

4 days ago

Singapore Antaes Consulting SA Full time

Senior DevOps Software Developer (L3 Production Support)
CDI
JOB DESCRIPTION:
We are hiring a Senior DevOps Software Developer for a project with an International Investment Bank.
The Senior DevOps Developer will take on a hands-on role to:
Contribute to Life Science projects for Antaes Asia clients
Support Manufacturing Operations in executing validation, trials, development, and technical transfer activities
Develop relationships within the Value Stream team and with other departments (MSAT, QA, QC TS, etc.)
Protocol generation or review for the assigned areas (i.e. process equipment, facilities, utilities, and laboratory equipment)
Generate, manage, and execute improvement initiatives in:

  • Electronic Batch records/SOPs
  • Process optimization.
  • Alarms management.

Operational Excellence (OE) initiatives Oversee changes including eCCs, SMRs, and SAP master data (e.g., BOM)
Address quality and business-continuity risks
Conduct gap analyses against QMS (CQMPs, GGs) and Quality Alerts
Plan, manage, and execute deliverables using proper and timely resources
Prepare documents and training materials for the operations department
Manage high-complexity deviation investigations and CAPAs related to process or technical events
Explain trends and support Manufacturing Operations in tracking process parameters
Coordinate effective utilization of ad-hoc team members (Manufacturing Operations Staff)
Contribute to the promotion of Antaes services on top of assistance provided to clients
Experienced Testing and Commissioning Engineer
CDI
As the Lead for site commissioning activities of radio-based train control systems, you will be responsible for overseeing Functional tests, System Acceptance Test (SAT), and System Integration Test (SIT) activities.
Responsibilities:
Lead site commissioning activities for radio-based train control systems, overseeing Functional tests, SAT, and SIT to ensure thorough testing of signalling system interfaces
Manage test and commissioning of On-Board, Wayside, and Radio systems
Collaborate with Engineering/suppliers for design changes based on test results
Record, report, and endorse test results as needed
Ensure timely, logical, and cost-effective testing activities
Work with the Engineering team to evolve drawings until the as-built stage
Build strong relationships with client teams to facilitate successful handover and post-implementation operation of projects
Plan and schedule site ITC activities aligned with the rolling and master program
Produce red corrections based on released drawings and rectify failures during the T&C phase
Raise NCR/MNCR/Fault reports for identified issues
Perform and review process engineering drawings and calculations, including but not limited to (heat exchanger sizing, pump selection, piping design, control valve sizing, heat and mass balances, and other engineered calculations)
Verify and validate calculations provided by vendors, clients, and other consultants to ensure accuracy and compliance with industry standards
Prepare and review technical data sheets for various equipment, instrumentation, and systems used in biologics manufacturing
Ensure all documentation aligns with the project’s technical requirements and industry best practices
Support the preparation and review of risk assessments, including Hazard and Operability Studies (HAZOPs), to identify and mitigate potential risks in the process design and operation
Collaborate in the preparation and review of automation sequences required for process automation, ensuring seamless integration with existing systems and compliance with regulatory requirements
Work closely with other engineering disciplines and cross-functional departments such as automation engineering, facilities engineering, validation, project management, operations, quality, and safety
Facilitate effective communication and coordination to ensure project success and alignment with overall business goals
Review Commissioning Project Plans, Validation Project Plans, Design Qualifications, Traceability Matrices, Commissioning Protocols, Qualification Protocols, and Validation Protocols for pharmaceutical equipment and systems
Ensure that all client process equipment and facilities operate as intended to meet biopharmaceutical manufacturing requirements
Provide ongoing support to the client’s plant operations, ensuring that engineering projects align with the changing needs of the business
Manage upstream and downstream equipment, as well as other unit operations, to optimize production efficiency and product quality
Implement projects addressing Corrective Actions/Preventative Actions (CAPA) identified during deviation investigations, requests from value stream stakeholders, or GMP audits
Offer on-the-floor troubleshooting support for manufacturing operations, with a focus on resolving equipment-related issues
Raise and lead GMP change requests for implementing changes to equipment and facilities, ensuring compliance with Good Manufacturing Practices (GMP)
Adhere to all applicable Environmental, Health, and Safety (EHS) requirements, ensuring that engineering activities support a safe and compliant workplace
Contribute to the promotion of Antaes services on top of assistance provided to clients
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