Experienced Process Engineer skilled in vaccine manufacturing facility installation, qualification, and cross-functional team coordination. Proficient in documentation practices and regulatory compliance. Seeking a Process Engineer role at an established organization.
Overview
3
3
years of professional experience
Work History
Process Engineer
Serum Institute of India Pvt Ltd
Pune
08.2021 - 08.2024
Worked on installation and qualification of various process equipment like bioreactors, mixers, centrifuges, hydrogen peroxide vapor generators, peristaltic pumps, etc.
Coordinated with cross-functional teams, such as QA, Project Engineering, and RA, for the smooth conduct of installation of vaccine manufacturing facility and equipment.
Prepared SAT(Site Acceptance Test) Reports for various equipment.
Engaged with vendors regarding functional testing of various equipment used for vaccine manufacturing.
Initiated Deviations, Change Controls, CAPA, as and when needed, for maintaining regulatory practices.
Provided insights about facility and equipment operations.
Handled software like EDMS(Electronic Data Management System), CMMS (Computerized Maintenance Management System), Track wise(Change Control Initiation and Tracking).
Worked on projects like multi-product manufacturing facility installations.
Education
Bachelor of Engineering - Chemical Engineering
AISSMS College of Engineering
Pune
05-2020
Skills
Design validation
Regulatory Standards
Performance improvement tracking
Relationship Building
Documents and reports
Affiliations
Enthusiastically participating in social awareness causing events.