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.

Someone shared one job with you. ASAI keeps finding the rest.

Scored, not searched. Every role ranked against your actual profile.

Alerts as often as hourly. Reach new roles while the pile is still small.

Skill gaps, spelled out. See exactly which requirements you don't meet yet.

Verified jobs, only. Say no to ghost jobs. Your time deserves respect.

Someone shared one job with you. ASAI keeps finding the rest.

Scored, not searched. Every role ranked against your actual profile.

Alerts as often as hourly. Reach new roles while the pile is still small.

Skill gaps, spelled out. See exactly which requirements you don't meet yet.

Verified jobs, only. Say no to ghost jobs. Your time deserves respect.

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.