Evaluate and execute process design engineering activities for sterile injectable / vaccine facilities for Formulation and Filling. Should be experienced in concept, design and fabrication, commissioning and qualification of process systems in cGMP environment.
Understand and execute the technology transfer of new solutions and modifications adhering ti regulatory compliance requirements.
Ensure that the project satisfies the project needs of budget and schedule needs.
Review and comment on the design and implement (Commissioning and Qualification) according to site and best practices.
Responsible for multiple systems of the project for design and operational effectiveness.
Requires degree in Chemical Engineering with 9 to 12 years of experience in the field of design, construction and installation of process equipment, process CIP/SIP systems.
Develop and review of URS, P&ID, PFD, specification of process equipment including Formulation, Liquid Filling, inspection and Packaging equipment/process and their control systems.
Participate in execution of FAT, SAT for equipment and start up, commissioning and validation.
Must be able to interface with consultants and contractors and to direct mechanical installations.
Knowledge on Chemical engineering Technology for process including Formulation, Liquid Filling, CIP/SIP systems including equipment installation and construction, piping & controls and project management functionality . Experience in C&Q and validation of process equipment is necessary.
Initiator / visualization
Regulatory / cGMP and Compliance knowledge
Basic Qualification required: Bachelor degree in Engineering