-Role & responsibilities 1. Preparation of project concept note and project definition. 2. Preparation of project milestone schedule. 3. Layout Review and to follow up with all stake holders for review & approval. 4. To Prepare CAPEX based on the realistic approach keeping the focus on overall project timelines, cost & technologies. 5. To timely escalate cost over runs or for the additional scope of work to Project Head. 6. Prepare and Review Planning/Schedule of overall project. 7. Review of Design Data Sheet (Utility, HVAC, Electrical). 8. Project monitoring, liaison and co-ordination with consultants, vendors, and cross functional team. 9. Utility designing and selection as per process / product requirement. 10. Preparation and or Review of URS of utility equipment. 11. Designing and selection of clean utilities based on consumption profile. 12. Preparation and or Review of technical comparison of all vendors. 13. Review of P & ID and documents. 14. Responsible for preparation & review of qualification, validation documents, SOPs & QMS documents. 15. Responsible for supervise all vendor activity for all streams. 16. Responsible for periodic revision of the list of approved layouts. 17. SOP and other required documents like Addendum study protocols preparation and review. 18. To monitor, review and update progress of execution and qualification activity for facility. 19. Ensure Site Readiness and allied activities are done with meeting required timelines. 20. Co-ordination with Purchase team for Equipment Ordering and Finalization. Preferred candidate profile - Candidate should have experience in Biotech/ Pharmaceuticals Industry - Experience in greenfield projects is must.
Role & responsibilities Lead and manage both the MES team and the Automation team, ensuring efficient project execution and alignment with organizational goals. Drive PAS-X MES implementation projects across various phases including design, development, testing, and deployment and Maintenance. Oversee integration of PAS-X MES with shop floor equipment & ERP, ensuring seamless data exchange and operational efficiency. Manage Level 2 integration efforts with shop floor equipment, focusing on systems like GE iFix SCADA, Kepware OPC, Siemens PLC, and SCADA systems. Directly engage in PLC and SCADA programming, troubleshooting, and equipment maintenance activities. Maintain PAS-X MES recipes and recipe authoring processes in collaboration with relevant stakeholders. Provide technical leadership and guidance to team members, encourage a culture of continuous improvement and technical excellence. Collaborate with cross-functional teams including IT, engineering, operations, and quality assurance to ensure successful project outcomes. Skill & Qualifications: Minimum of 6 years of experience in PAS|x MES implementation within the pharmaceutical industry and over all Min 10 years of experience in pharmaceutical Industry. Proven experience in integrating MES with shop floor equipment & ERP, particularly with Level 2 systems and SAP. Proficiency in GE iFix SCADA, Kepware OPC, Siemens PLC, and other relevant automation/ Historian technologies. Hands-on experience in PLC and SCADA programming, configuration, and troubleshooting. Strong understanding of equipment maintenance practices and methodologies. Experience in MES recipe authoring and managing recipe lifecycles. Strong analytical and problem-solving abilities, with a keen attention to detail. Bachelors degree in engineering Instrumentation/Computer Science, or related field. Familiarity with regulatory requirements and standards in the pharmaceutical industry (e.g., GMP, FDA regulations). Preferred candidate profile Candidate should have experience in biotech industry