Job Description

The candidate should establish Process automation functionality for Development labs and cGMP facility for Lambda CDMO. The role entails utilization of the prospective candidates vast technical experience to execute and run a team that will be focused on day-to-day work of Process automation and its integration in compliance environment. Candidate should be subject matter expert in implementation of digital platforms (e.g. MFCS, Unicorn, ELN, LIMS, Empower, Chromeleon, CDS, AVEVA Pi and eLog Book) Specific Job Responsibilities: Plant Automation Systems Management: Maintain and optimize plant automation systems, including SCADA, PLC and IPC systems with L2 integration. To organize for and maintain the latest software for PLCs, HMIs and SCADA in plant and QC. Troubleshooting and Resolution: Troubleshot and resolve issues promptly to minimize downtime and ensure operational efficiency for critical biopharmaceutical equipment like bioreactors, chromatography systems, robotic filling lines, QC and analytical equipments. Automation Recipe Development: Create and validate process automation recipes for biopharma equipments like Bioreactors, Chromatography, TFF systems, HPLC systems, liquid handling units L1-L4 Integration: Drive the automation aspects of integration across L1 (data from instruments/equipment), L2 (e.,g SCADA/PLC), L3 (e.,g EBR), L4 (e.,g Historian) Functional Specification: Review of functional specification documents from instrument / equipment vendors for automation aspects. 6. Active Involvement in MES Project Activities: Play a key role as a core team member in overseeing and driving MES (Manufacturing Execution System) project activities along with users and IT. Manage and supervise tasks related to L2 Integration activities to support MES utilization. Develop and executed project plans for MES implementation and automation system. Assist in preparing and reviewing Standard Operating Procedures (SOPs) and work instructions related to the MES project. Serve as the SME for selecting technical specifications of MES infrastructure package materials, including MES software licenses and various hardware components such as tablets, printers, barcode scanners. 7. Project Coordination: Coordinate with the team according to project schedules to monitor, track and ensure progress. 8. Cross-functional Collaboration: Collaborate with cross-functional teams, including end-users, IT, operations, and quality assurance to facilitate the seamless integration of MES with ERP, weigh scale, and L2 systems. 9. Efficient Management of Project Material Procurement and Installation: Manage the procurement and installation of project materials, ensuring timely delivery and adherence to project timelines. 10. Compliance with Health, Safety, Environment, and Energy Policies: Ensured adherence to Environment, Health and Safety policies to maintain a safe and compliant workplace Provide support during regulatory inspections. 11. Adherence to Good Documentation Practices and Data Integrity: Ensured compliance with Good Documentation Practices (GDP) and Data Integrity requirements during all GxP operations and documentation at the site. 12. Data Breach Management: Ensured that any potential data breach is addressed in accordance with the SOP for Handling of Potential Data Integrity Observations Core Competencies Should be a bio-pharma industry expert in process and analytical automation. Strong organizational skills, including the ability to prioritize personal and direct reports workload. Abreast with the latest technical innovations and familiarity with Regulatory expectations Analyzing automation problems and providing inputs for change. Very good understanding and implementation of the automation across CDMO functions and electronic record keeping. Sufficient industry experience in handling cross functional interactions. Resolving inter departmental challenges through a process of strong rationale while adhering to the expectations of the requirements of different functional groups. Relevant Functional/Technical Skills or Industry Experience Responsible for preparation and review of documentation related to qualifications of LIMS, ELN and any other digital platforms. Responsible for automation related troubleshooting. Knowledge of systems like Siemens, X works, Delta V DCS Knowledge of Java, C++, Python advantageous. Experience working with control panels and PLC control systems Experience in troubleshooting and set up support for automation for biopharmaceutical equipment like bioreactors, robotic filling equipment, chromatography systems. Strong knowledge of industry-specific regulations and standards. Ensuring the quality and suitability of systems installed in the CDMO facility for maintaining integrity and safety. Technical competence in appropriate scientific discipline or technology will be of great value. Strong Cross functional communication skills is highly desirable. Excellent oral and written communication and interpersonal skills will be desired. Relevant Professional / Educational Background: BTech/MTech/BE in Electrical Engineering / Computer Engineering/Information Technology / Control Systems Engineering / related Branch of Engineering with 8 to 12 years of relevant work experience in Process and analytical Automation and digitization for biopharma/biotech or relevant contract research labs. The preference will be for personnel who have prior experience in Process and analytical Automation and its compliance. Work experience on digital compliance in the bio-therapeutic industry will be an added advantage.