Site Engineer
1 month ago
Role: Commission & Qualify (as per Regulatory requirements) Systems / Equipment's / Plants conforming to pre-Approved Site Acceptance Test (SAT) Protocols at Customer's Site
Education Qualification: BE / BTech in Mechanical / Instrumentation / Biotech / Chemical Engineering
Years of Experience: 3 to 6 years
Travel Requirement: Definitely, PAN INDIA
Accountable and Responsible for :
Carrying Out:
- Site piping by contractors
- Installation & Qualification
- Equipment Qualification
- Process Validation
- Performance Testing
- System Integration Testing
Preparing:
- Validation Protocols (SAT)
- Standard Operating Procedures (SOPs)
- Change Control Management, NCR (Non-Conformance Report)
- Documentation & Reporting
- Validation Master Plan (VMP)
Experience in:
- Risk Management
- Regulatory Compliance (e.g., FDA, EMA)
- Functional Testing as per Approved FDS
Behavioural Skills:
- Should be Knowledge-wise on top of his game. He should be confident on his work and should be able to stand his ground in the event he feels he is professionally-&-technically in the right. Flexibility, while desired, should be exercised with the full knowledge of Cost-&-Time implications.
- Should have a keen eye for Details and should readily be able to spot Errors/Discrepancies/Deviations in Site-installations, Drawings, Data Sheets, Commercial Offers, Purchase Orders, Commercial Agreements etc.
- Should have a pleasant personality and should be able to resolve Doubts, Differences, Disputes without sacrificing the interests of DDE. While Customer friendliness, is desirable, it should manifest without the loss of Technical prudence or Professional integrity.
- Since, he shall be the Representative / Face of DDE at the Site, his behaviour and demeanour should be fitting to the image and reputation of the Company. Assignments completed by him should result in the confidence of the Customer for unhindered calls/mails to him should the Customer so feel the need.
- Should have the persona of a Leader.
Key Performance Indicators:
- Minimal, if not Zero, Non-compliances be it Technical, Regulatory, Commercial or Personnel.
- Minimal, if not Zero, Cost & Time overruns of Site assignments.
- Completeness and Accuracy of all Site Documentation --- in Quantity and Quality.
- An impressive List of DDE's Customers with whom he notches up a "First-name Call"
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