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CQV Engineer

5.00 to 7.00 Years   Hyderabad   18 Aug, 2022
Kalindi Prakash Gadkari Hiring For Pharma Consulting & Engineering Company
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaSite Engineering / Project Management
EmploymentTypeFull-time

Job Description

    Responsible for providing direct services to site Technical Servicesmanagement, aiding to increase the throughput of commissioning,qualification, and validation activities through the department andacross the site.2. Review site commissioning and qualification documentation foraccuracy, technical soundness and compliance to both site andregulatory guidelines.3. Project will include new facilities/equipment startup, commissioning,FAT, manufacturing equipment qualification, laboratory equipmentqualification and computerized and automation systems includingFMS and BMS systems.4. Provide support for the development of user requirement andfunctional specifications.5. Support the generation and execution of all commissioning andqualification documentation related to demonstration batches,thermal studies, validation studies for equipment, facilities, utilities,engineering test runs, development studies, software validation andfinal reports.6. Recommends to management as to the acceptance and release ofqualified systems.7. Actively participates during all phases of validation projects.Evaluates projects, provides technical information to others.8. Review technical and quality system documents such as SOPs,Change Control and Deviation Reports, Batch Production Records,Technical Manuals, P&IDs, construction, as-built, flow diagrams asthey relate to validation principles and regulatory complianceissues.9. Review various documentation and drawings to ensure anydocument changes, meet quality and validation requirements andare in full compliance with regulations and standards.10. Support, investigate and troubleshoot problems and determinepossible solutions.11. Preparation of PFD, URS, FDS, Cycle Time Analysis etc.12. Calculation for Utilities, Peak Loads, Pipe/Pump sizing, Equipmentcapacity, and other accessories capacity/load/size13. Preparation of P&ID, TS, DS, BOQ, Tender, Validation documents(VMP, FAT, IQ, OQ, PQ etc)14. Equipment/Instrument Selection, Vendor Evaluation, Techno-commercial Report Preparation15. Site execution of validation activitiesEducation & Other requirement -BE Chemical / Biochemical/ Biotechnology 5 Years of relevant experience in Pharma and Biotec projectsdownstream processes/ Sterile, API, OSD etc. Process / Design Engineer from Consulting & Engineering(Pharmaceuticals/Biotech) Companies- Preferred Process Engineer / Project Engineer from Finished Pharmaceuticals(Sterile API, Parenteral), Biotech., & Fermentation Industries Design Engineer from Equipment Manufacturing Companies

Keyskills :
validationproject management

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