CQV Engineer - Biotech & Pharma (F/M)

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:

• Implement all necessary tools to manage the environments, the continuous integration, the continuous delivery, and the processes execution.
• Manage and administrate environments from assembly to production (rules included), infrastructure implementation, and operational usage.
• Execute the maintenance operations, delivery, and environment monitoring.
• Provide L3 support on non-production environments for delivery teams and also on production for support teams.

Job Responsibilities:

• Participate in the automation of the deployment solution
• Participate in environment preparation for testing phases
• Participate in developing tools to simplify day-to-day activities on the program
• Facilitate coordination between program developers and infrastructure engineers
• Ensure continuous improvement and maintenance of the CI-CD pipeline
• Provide investigation help while fostering knowledge and sharing best practices with team members
• Research, design, and develop software
• Analyse user needs and develop software solutions
• Update software, enhance existing software capabilities, and develop and direct software testing and validation procedures
• Work with other engineers to integrate hardware and/or software systems
• Develop specifications and performance requirements

Job Description:

• 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.

- Materials 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

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.

Job Description:

• Contribute to Life Science projects for Antaes Asia clients
• 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

Context:

• Capital Market IT applications (in-house and package) used worldwide, covering Front Office (Murex, Apex, Orchestrade…), Back Office (Summit, Calypso…), Market data referential (Asset Control...), Market Risk (in-house application on big data technologies).
• This role aims to develop on the Calypso back-office package, in project mode as well as maintenance, and to support the “run the bank” function. It requires a deep understanding of the nature of business operations, timing of activities & data flowing through internal and external systems. The build and support team continuously works with business users, infrastructure engineers and system managers.

Job Description:

• Contribute to IT initiatives for Antaes Asia clients
• Build & change management

1. Analyse enhancement requests for the repo business and new products.
2. Propose solutions in collaboration with Architects.
3. Specifications, workload estimates, planning, test scenarios, release documentation.
4. Coordinate user acceptance tests.
5. Monthly releases, following the team’s milestones for analysis, coding and testing.
6. Support the release roadmap in production.

• Incidents and Requests management (business users and other IT teams.

1. Application support, level 3 (expert).
2. Troubleshoot and fix issues/bugs.

• Continuous improvement

1. Improve operational processes.
2. Coach more junior team members as required.

• Contribute to the promotion of Antaes services on top of assistance provided to clients