Company Description At ProvenTech, we are leaders in digital innovation, specializing in development, implementation, and support for the Life Sciences and Healthcare sectors, including pharmaceuticals, biotech, and nutrition. Our expertise lies in revolutionizing manufacturing processes with Industry 4.0 and Pharma 4.0 technologies, driving productivity and operational efficiency. We design and deliver secure, scalable, and stable systems tailored to unique business needs, providing end-to-end solution architecture for sustainable growth. Our customer-centric approach, combined with cost-effective solutions and domain expertise, ensures that we deliver products aligning with clients' vision, empowering them to achieve success. Role Description We are seeking a highly motivated and detail-oriented individual to join our team as a LIMS Master Data Creation Specialist. In this role, you will be responsible for the accurate and timely creation and maintenance of master data within our LIMS platform. The successful candidate will possess a strong understanding of laboratory workflows and data management principles, along with excellent organizational skills and the ability to work independently and collaboratively within a team environment. Key Responsibilities: Utilize knowledge of laboratory processes and terminology to accurately translate requirements into LIMS master data configurations. Collaborate with laboratory staff and project stakeholders to gather requirements for master data creation and ensure alignment with business needs. Configure LIMS system settings, including sample types, test methods, analytical procedures, and other relevant parameters. Input and validate data in accordance with established Procedures and quality standards. Perform routine data maintenance tasks, including updates, corrections, and archival of obsolete data. Troubleshoot Master data-related issues and provide timely resolution to ensure system integrity and reliability. Document master data creation processes, standard operating procedures (SOPs), and system configurations. Provide training and support to end-users on master data management best practices and system usage. Collaborate with cross-functional teams, including IT, quality assurance, and laboratory operations, to support system integration and enhancement initiatives. Stay informed about industry trends and emerging technologies related to laboratory informatics and master data management. Show more Show less

Job Title: Pharma Manufacturing Process Analyst / Manufacturing Systems Specialist Job Summary: We are seeking a skilled Manufacturing Systems Analyst with strong domain expertise in pharma manufacturing processes and experience working with pharmaceutical manufacturing systems (MES, SCADA, DCS, Historian systems, etc.). The role involves review and analysis of manufacturing data, including audit trail reviews , alerts , and alarms monitoring , to support digital operations and ensure regulatory compliance. Key Responsibilities: Act as a functional SME for pharma manufacturing processes , providing process insights to support system operations and investigations. Review and analyze audit trail data generated from manufacturing systems to ensure data integrity and compliance with ALCOA+ principles. Perform periodic review of alerts , alarms , and exception logs as part of routine monitoring and deviation investigations. Collaborate with production, QA, and IT teams for resolution of issues related to manufacturing systems. Support the digitization and continuous improvement initiatives in manufacturing areas. Participate in system validations, including URS development, system configuration reviews, and functional testing. Prepare and maintain SOPs and system documentation related to manufacturing systems usage and monitoring. Train end-users on manufacturing systems functionalities and regulatory requirements. Required Skills and Qualifications: Strong understanding of pharma manufacturing processes (Batch Processing, Equipment Usage, Environmental Monitoring, etc.). Hands-on experience working with Pharma Manufacturing Systems (MES, DCS, SCADA, Historian platforms). Good knowledge of audit trail review and interpretation of manufacturing system logs. Understanding of alerts , alarms , and deviation data as part of electronic record review. Familiarity with data integrity guidelines (21 CFR Part 11, EU Annex 11, WHO TRS). Experience in handling system compliance documentation (SOPs, URS, validation reports). Ability to collaborate effectively with QA, Manufacturing, and IT stakeholders. Preferred Qualifications: Knowledge of GAMP 5 , CSV principles, and pharma regulatory requirements. Experience in data review from systems like Siemens Simatic, Emerson DeltaV, Rockwell Automation, PAS-X, or similar MES/DCS platforms . Exposure to Industry 4.0 and digital transformation initiatives in manufacturing.