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