About the role
Engineering: Instrumentation & Calibration – Senior Executive Calibration Schedule Execution: Plan, execute, and oversee routine and breakdown calibration activities for all critical process and utility instruments across Granulation, Compression, Sterile processing, and Utilities. QMS & Deviation Management: Drive Engineering QMS compliance by leading technical investigations for Out-of-Calibration (OOC) events, instrument-related Deviations, CAPAs, and Change Control implementations. Calibration Master Plan (CMP) Maintenance: Maintain and update the site Calibration Master Plan, establishing calibration frequencies, tolerances, and drift limits for field instruments (e.g., RTDs, pressure transmitters, load cells, flow meters). Audit Representation & SME: Serve as the Subject Matter Expert (SME) during internal, customer, and regulatory audits (USFDA, EU Annex 1, MHRA), presenting calibration certificates, loop diagrams, and instrument master logs. Loop Testing & Qualification: Coordinate and execute instrument loop testing, functional testing, and equipment re-qualification (IQ/OQ/PQ) for new machinery, SCADA systems, and automated control loops. Data Integrity & SCADA Compliance: Ensure full compliance with ALCOA+ and 21 CFR Part 11 principles across all electronic instrument records, automated calibration software, PLC parameters, and recorder data logs. Vendor & Standards Management: Manage external calibration agencies and OEMs; verify traceable master instrument certificates (NIST/NABL) and audit vendor execution dossiers. Preventive Maintenance (PM): Develop, execute, and track preventive maintenance programs for field sensors, control valves, actuators, loop controllers, and analytical instruments (e.g., pH, conductivity meters). SOP Authoring & SOP Revision: Draft and update SOPs for instrumentation maintenance, calibration procedures, standard operating limits, and emergency troubleshooting protocols. EHS & Cleanroom Discipline: Enforce strict adherence to plant Environmental Health & Safety (EHS) policies, permit-to-work systems (hot work, electrical), cleanroom gowning, and workplace 5S standards.