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
Job Requirements:
- Bachelor’s Degree in Biomedical Engineering, Biotechnology, Science or equivalent
- Minimum 2+ years of pharmaceutical, biopharmaceutical experience in Process Engineering and/ or Compliance (GxP) environment
- Ability to quickly know products and processes in order to assess quality issues
- Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
- Demonstrated good knowledge of technical drawings, general arrangement drawings, and equipment design drawings (P&ID) is required.
- Experience in the design and operation of biopharmaceutical manufacturing equipment and facilities.
- Experience in the management and coordination of engineering and construction management consultants, equipment vendors and contractors.
- Excellent communication skills, both written and verbal, in English
