Senior Officer, Autoclave

3-7 Years

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Early Applicant

Job Description

Job Description

Responsibilities A) Design Review & FAT

Review chamber design, door mechanism, gaskets, and loading accessories.
Observe FAT cycle demonstrations (pre-vac, porous, liquid cycles) and HMI screens.
Understand load configuration principles and basic steam/air removal concepts.
Verify steam quality needs, drain gradient, and chamber accessories at FAT.
Review safety valves, sensors, recorders, and interlock logic.
Assess vacuum system performance and air removal efficiency.

B) SAT / IQ / OQ / PQ

Support SAT/IQ: piping verification, drain mapping, and utility readiness checks.
Execute sterilization cycles; collect and file printouts and parameter records.
Assist PQ load pattern runs and sampling per protocol.
Lead OQ: heat distribution, penetration studies; temp/pressure mapping support.
Troubleshoot cold spots, air pockets, leak tests, and door integrity.
Coordinate calibrations and document qualification results.

C) Routine Production

D) GMP, EHS & Compliance

E) Documentation

Complete BMR/BPR entries, equipment logbooks, cleaning and line clearance records.
Support deviation/CAPA, change control, and risk assessments as applicable.
Maintain qualification/validation records during SAT, IQ, OQ, PQ.

Skills & Competencies

Technical: Understanding of equipment design, utilities, interlocks, and control logic.
Operational: Setup, start-up/shutdown, parameter verification, basic troubleshooting.
Behavioral: Attention to detail, teamwork, communication, ownership mindset.

Qualifications

Education & Experience

ITI/Diploma (Mech/Elect/Instr) / B.sc or B.Tech preferred.
3 to 7 years of experience in sterile injectable manufacturing with hands-on equipment operation, FAT/SAT participation, troubleshooting, and qualification exposure (IQ/OQ/PQ).