16 Iso 14644 Jobs

we are Hiring for Mechanical Design Manager ( Medical Devices ) Candidates for our Medical devices company in Singadivakkam village Kanchipuram .We need only candidates from Health Care, Medical Devices and Pharma Sectors Mechanical Design Manager Medical Devices Location: Singadivakkam Village, Kanchipuram (Chennai) Experience: 10 to 18 Years Company Overview Global-standard medical device design and manufacturing organization. Specializes in precision engineering, high-reliability components, and system solutions for healthcare and medical OEMs. Operates under strict quality, regulatory, and compliance frameworks. Role Summary Lead mechanical design activities for medical devices from conc...

Job Description: The HVAC Engineer (Site Execution) is responsible for overseeing and managing all site-level HVAC activities for cleanroom and controlled-environment projects under a Project Management Consultancy (PMC) framework. The role ensures that HVAC works are executed in compliance with project specifications, approved drawings, quality standards, and schedule requirements. Key Responsibilities: 1. Site Supervision & Coordination Supervise HVAC system installation activities for cleanroom areas, ensuring adherence to design specifications, drawings, and approved material submittals. Monitor subcontractors daily activities, manpower, and progress against the project schedule. Coordin...

Microbiological testing, monitoring & sterility assurance, Initiate CAPA, Generate & execute microbial method validation protocols/report, Microbiology procedures, validations, records including writing, routing, approval for Medical Device Industry. Required Candidate profile BSc/ MSc in Microbiology with 1+ year exp. as a Microbiologist in a medical device company. Hands-on with microbiology standards including AAMI ST72, ISO 11737, ISO 14644, ISO 11137, ISO 11135, USP.

Project Planning & Scheduling Understand clean room classification (ISO 14644, GMP) and HVAC requirements Coordinate with design consultants for HVAC layouts, AHU sizing, ducting, and cleanroom utilities

Assist in the planning, designing, and drafting of HVAC layouts, duct routing & Cleanroom systems utility designs for pharma & industrial projects apply cleanroom classifications (ISO 14644, GMP) Drawings using AutoCAD or relevant design software

Job Title: Senior Trainer Validation (CQV, Equipment, Injection Mold, HVAC) Location: Remote Job type: Part-time Job Summary: To design, develop, and deliver comprehensive training programs on Commissioning, Qualification & Validation (CQV), Equipment Qualification, Injection Molding Process Validation, and HVAC System Validation. The trainer will ensure technical competency development across engineering and quality teams in compliance with international regulatory standards (USFDA, EU GMP, ISO 13485, etc.). Key Responsibilities: Develop and deliver training modules on: Commissioning, Qualification, and Validation (CQV) lifecycle Equipment Qualification (IQ/OQ/PQ) Process Validation for Inj...

Assist in the planning, designing, and drafting of HVAC layouts, duct routing & Cleanroom systems utility designs for pharma & industrial projects apply cleanroom classifications (ISO 14644, GMP) Drawings using AutoCAD or relevant design software

Project Planning & Scheduling Understand clean room classification (ISO 14644, GMP) and HVAC requirements Coordinate with design consultants for HVAC layouts, AHU sizing, ducting, and cleanroom utilities

Project Planning & Scheduling Understand clean room classification (ISO 14644, GMP) and HVAC requirements Coordinate with design consultants for HVAC layouts, AHU sizing, ducting, and cleanroom utilities

Assist in the planning, designing, and drafting of HVAC layouts, duct routing & Cleanroom systems utility designs for pharma & industrial projects apply cleanroom classifications (ISO 14644, GMP) Drawings using AutoCAD or relevant design software

Prepare and review detailed HVAC drawings including layouts, sections, elevations, and schematics. Develop HVAC designs specifically for cleanroom facilities, pharma, biotech, and controlled environments. Required Candidate profile -AutoCAD, Revit, SolidWorks, or similar drafting/design software. -In-depth understanding of GMP norms, ISO 14644, and cleanroom classifications. -Strong problem-solving, communication,teamwork skills

Assist in the planning, designing, and drafting of HVAC layouts, duct routing & Cleanroom systems utility designs for pharma & industrial projects apply cleanroom classifications (ISO 14644, GMP) Drawings using AutoCAD or relevant design software

Project Planning & Scheduling Understand clean room classification (ISO 14644, GMP) and HVAC requirements Coordinate with design consultants for HVAC layouts, AHU sizing, ducting, and cleanroom utilities

Job Description: Site Project Engineer (HVAC & Cleanroom Projects) Company: Syntec Airflow Systems Location: Project Sites in and around Gurugram, Haryana Job Type: Full-Time About Syntec Airflow Systems: Syntec Airflow Systems is a leading provider of advanced HVAC and turnkey cleanroom solutions. We specialize in designing, manufacturing, and installing precision-engineered environments for critical industries, including pharmaceuticals, biotechnology, microelectronics, and healthcare. Our commitment to innovation, quality, and client satisfaction has made us a trusted partner in delivering state-of-the-art controlled environments. Job Summary: We are seeking a dynamic, detail-oriented, an...

Responsible for Generation of Validation reports & Air Flow Pattern test video all site. Filling vendor registration form. Preparing quotation & sending to Customer after follow up. Preparing Validation Report. Preparing instrument calibration schedule. Scanning and maintaining calibration traceability of instruments in soft and hard copy. Weekly updating validation instrument in stock with co-ordination of validation team. Develop and maintain a QMS compliant with ISO 14644-1,2,3 and related industry standards. Note : Only Female candidates are preferred

Microbiological testing, monitoring & sterility assurance, Initiate CAPA, Generate & execute microbial method validation protocols/report, Microbiology procedures, validations, records including writing, routing, approval for Medical Device Industry. Required Candidate profile BSc/ MSc in Microbiology with 3+ year exp. as a Microbiologist in a medical device company. Hands-on with microbiology standards including AAMI ST72, ISO 11737, ISO 14644, ISO 11137, ISO 11135, USP.