Role & responsibilities

Responsibilities

- Perform routine calibration of temperature, pressure, flow, level, conductivity, pH and weighing instruments per the calibration schedule
- Carry out preventive and breakdown maintenance of PLC/SCADA-linked instruments, sensors, transmitters and control valves
- Prepare and maintain calibration records, logbooks and certificates, following ALCOA+ data integrity
- Support IQ/OQ/PQ execution and requalification activities
- Handle instrument-related deviations, with first-level investigation support
- Maintain calibration standards, traceability to NABL/NIST and spare parts inventory
- Follow safety, gowning and aseptic area entry procedures

Senior Executive

Qualification: B.E./B.Tech in Instrumentation or Electronics. Experience: 5-8 years, with sterile injectable exposure.

Additional responsibilities

- Lead the calibration and instrument maintenance schedule and supervise technicians and contract staff
- Own investigations, root cause analysis, CAPA and change controls for instrument and automation issues
- Review and approve calibration and qualification documents; author SOPs and protocols
- Manage PLC/SCADA/DCS troubleshooting, alarm management, audit trail review and user access controls (21 CFR Part 11)
- Support regulatory and customer audits (USFDA, EU, WHO, MHRA) and respond to observations
- Support current equipment procurement, FAT/SAT, commissioning and project execution
- Drive reliability improvements, spare strategy, vendor evaluation and cost control

2. Process Mechanical

Common scope: Mechanical maintenance, installation and reliability of process and utility equipment in injectable manufacturing.

Executive





Qualification: B.E./B.Tech/Diploma in Mechanical Engineering. Experience: 2-5 years in pharma, preferably sterile.

Responsibilities

- Perform preventive and breakdown maintenance of filling machines, vial washers, autoclaves, lyophilizers, capping and sealing machines, mixing vessels, pumps and process piping
- Execute lubrication, gasket/seal and format-part changes, and mechanical alignment checks
- Maintain equipment history cards, PM checklists and maintenance logbooks
- Support IQ/OQ/PQ and requalification, including orbital weld and passivation documentation
- Assist with cleaning, sanitization and SIP/CIP-related mechanical activities
- Maintain spares inventory and raise material requisitions
- Follow permit-to-work, lockout-tagout, EHS and cleanroom discipline

Senior Executive

Qualification: B.E./B.Tech in Mechanical Engineering. Experience: 5-8 years, with sterile injectable exposure.

Additional responsibilities

- Plan and supervise the PM schedule, shutdown activities and manpower deployment
- Lead breakdown analysis, root cause investigations, CAPA, deviations and change controls
- Own sanitary design aspects: hygienic piping, orbital welding, surface finish, drainability and dead-leg control
- Review and approve maintenance SOPs, qualification protocols and reports
- Support audits and respond to regulatory observations
- Support projects: URS, equipment selection, FAT/SAT, installation, commissioning and handover
- Track KPIs (downtime, MTBF/MTTR, PM compliance) and drive reliability and cost-saving initiatives
- Coordinate with Production, QA, Validation and vendors

Preferred candidate profile

📌 Process Instrumentation / Process Mechanical - Exe / Sr. Exe (Hyderabad)
🏢 Aspiro Pharma
📍 Hyderabad