The role is responsible for Equipment Package Ownership (full lifecycle – Engineering Design, Build, Testing (FAT), Installation and Commissioning), including experience in commissioning and qualification of process equipment.
Responsibilities:
● Experience in upstream / downstream / Central services process operation, (experience in equipment design for process equipment will be an advantage).
● Project scheduling and able to come up solutions to keep the schedule on track when there are hiccups.
● Responsible for basic and detailed design, commissioning and qualification activities, including URS development, FAT, SAT, DQ, IQ, OQ and PQ.
● Review industry practices for best-in-class approach.
● Ensure that the appropriate Quality standards are applied consistent with best practice and internal Quality Standards and expectations.
● Deliver the project from conceptual through implementation phase, encompassing support for a wide range of engineering and construction requirements.
● Coordinates with different functions like manufacturing, safety, MSAT, validation and quality for implementation of changes associated with the project.
● Work independently and/or with the project manager to complete the engineering projects within schedule, budget and quality constraints.
● Agile response to equipment issue, troubleshoot and come up with solutions swiftly.
● Any other task as assigned by Supervisor/Manager.
About You:
● Diploma/Degree in Chemical Engineering, Chemistry or equivalent with at least 5 yearss experience in a process engineering role or similar role with a biologics manufacturing plan.
● At least 5 years of relevant working experience in the Pharmaceutical / Biologics manufacturing industry with experience in Process Engineer.
● In Biologics industry with understanding of cGMP requirement.
● Should have Design experience at various stages of project (Base, Detailed design).
● Able to support Installation, Commissioning & Qualification activity at site.
● Must be able to drive project.
● Any other task given related to Process.
Contract length: 12 Months. Option to extend depending on performance and business needs.
