Job Description:
- Contribute to Biopharma projects for Antaes Asia clients
- Lead projects through the design, procurement, installation and commissioning of new equipment or modifications to existing equipment, facilities and engineering assets, in order to meet operational and reliability requirements for existing product and/or new product introduction
- Collaborate with internal resources and/or external contractors to plan, schedule and execute capital projects within established timelines and budgets.
- Ensure equipment and piping design conforms to industrial standards, master specifications, statutory requirements, SHE standards, cGMP compliance and other necessary requirements.
- Create, review and/or approve cGMP documents such as SOPs, engineering drawings, change orders, etc. and maintain project documentation as necessary.
- Partner with maintenance and utility teams to ensure maintenance requirements are duly considered in asset design, support updating of maintenance procedures/work instructions and imparting capabilities for asset maintenance.
- Partner with reliability teams to provide information for setting up maintenance master data, contribute to total asset lifecycle management and support reliability initiatives for all F&E assets.
- Assist in preparation of capital budget. Support the technology transfer of new products/ processes to Singapore site as required. Support qualification of new equipment or modifications to existing equipment as required.
- Support risk assessments, impact assessments and implement CAPA as required.
- Support in raising Planned event records in Veeva change management system to get gmp impacting project scope approved for execution.
- Comply with all RSTO's Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable.
- 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
- At least 5 years' experience as a design/project engineer/process engineer or related technical discipline in the pharma/biotech industries
- Advanced knowledge of engineering concepts, master specifications, equipment validation and qualification, safety principles, quality systems and cGMP requirements
- Working knowledge of site finance and procurement policies relating to capital projects. Working knowledge/experience of procedures related to construction, field safety, welding/installation, passivation, polishing and cleaning etc.
- Experience in working with Veeva planned events change management system is preferred
- Able to develop solutions to complex problems using sound engineering judgment and advanced engineering knowledge
- 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
