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).
- 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.
- Engage with project teams to 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, project engineering team, 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.
- Any other task as assigned by Supervisor/Manager.
About You:
- Diploma/Degree in Chemical Engineering, Chemistry or equivalent with at least 5 years' experience in a process engineering role or similar role with a biologics manufacturing plan
- At least 2-5 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)
- Preferably handling the Autoclave, Glove box, CIP Skid during project phase
- Able to support Installation, Commissioning & Qualification activity at site.
- Any other task given related to Process.
