Engineering - Sr. Executive - Instrumentation

USV PRIVATE LIMITED; Daman; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

USV PRIVATE LIMITED in India seeks a Senior Executive for Instrumentation & Calibration to lead calibration across Granulation, Compression, Sterile processing, and Utilities, ensuring QMS alignment and data integrity.

You will maintain the Calibration Master Plan, drive deviations and CAPAs, and represent the site in audits by USFDA, EU Annex 1, and MHRA, coordinating IQ/OQ/PQ for new equipment and SCADA systems.

Responsibilities

• 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.

Job description

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.