DAMAN · FULLTIME
Engineering - Sr. Executive - Instrumentation
USV
Daman · onsite · Posted 9d ago
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Section · 01
About this 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.
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Section · 02
Skills
Audit RepresentationSOP AuthoringCalibrationData Integrity SCADA ComplianceEHS Cleanroom DisciplineLoop Testing QualificationQMS Deviation ManagementVendor Standards Management
Section · Company
About USV
USV
Pharma
7.1k+
employees
1961
65 years old
Mumbai, Maharashtra
India
About
USV India is the top old leading healthcare industry & pharmaceutical company in Mumbai, India. They provide API, Peptides, Biosimilars, Injectables, Ophthalmics & Solid Orals products in India
Industries
PharmaManufacturing
Employee ratings
1,753 reviews
4.0/ 5
Culture
3.8
Career growth
3.5
Work-life
3.8
Employees rate it well for
Work Culture220Salary137Senior Management115Work Environment110Appraisal91
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