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 sanofi 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.
Collaborate with plant HSE at Site with project activities ensuring all safety and environmental guidelines are adhered during construction and Technical Competencies
Essentials: 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.
Desired: 1.Proactive ness 2. Assertiveness 3. Communication 4. Initiator / visualization 5. Regulatory / cGMP and Compliance knowledge 6. LEAN Familiarity 7. Knowledge in proved technology and improvement.8. Asceptie processing and isoleted Technology
Qualification: BE/ B.Tech Chemical Engineering.
Candidate should have Experience in Pharma industry