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DDE Bioengineering Pvt. Ltd.
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Commissioning & Qualification Engineer

Commissioning & Qualification Engineer

DDE Bioengineering Pvt. Ltd.

4 - 8 years

0 Lacs

andhra pradesh

Posted:1 week ago| Platform: Shine logo

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Skills Required

commissioning risk management compliance testing regulatory compliance equipment qualification audit trail site piping installation qualification validation protocols iqoq functional performance testing documentation change control deadlegs slope asme bpe code eu guidelines for cq csv of system cipsip sterile industryformulation change control management ncr nonconformance report documentation reporting site schedule

Work Mode

On-site

Job Type

Full Time

Job Description

As a Commission & Qualify professional, your role involves conforming Systems, Equipment, and Plants to pre-approved Site Acceptance Test (SAT) Protocols at the Customer's Site. You will be accountable and responsible for the following key activities: - Coordinate with clients for SAT activities, plans, and execution. - Coordinate with the team to resolve site/service issues and provide necessary guidance. - Review site activities according to the given schedule and escalate if there are delays. - Manage site costs and drive continuous improvement processes. - Manage the team, including resource planning, appraisal, training, and grievance handling. - Carry out Commissioning, Site Piping, Installation & Qualification. - Implement Validation Protocols (SAT), IQ/OQ. - Conduct System & Equipment Validation, Process Validation. - Manage Risk, Compliance Testing, Functional & Performance Testing. - Handle Documentation & Change Control (NCR). - Ensure Regulatory Compliance (FDA, EMA). - Implement Deadlegs, Slope, ASME BPE Code, EU Guidelines for C&Q. - Execute the 4 Stages of Equipment Qualification & CSV of the System. - Implement Audit Trail, CIP/SIP, Sterile Industry/Formulation. Your responsibilities also include carrying out Installation & Qualification, Equipment Qualification, Process Validation, OQ & CSV (Computer System Validation), as well as preparing Change Control Management, NCR (Non-Conformance Report), Documentation & Reporting, and Site Schedule (IQ & OQ). The role requires a Graduation/PG degree in Engineering, Biotech, or Chemical with 4 to 6 years of experience in the field.,

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Commissioning & Qualification Engineer