Packaging, Sterilization and Cleanroom Executive and Engineer

• Perform Validation as per Medical Device Quality System as per ISO 13485, Clean room, 14971 and Sterilization as per ISO Standards.
• Prepare and control BPR, Label Sheets, batch production and document PDIR (Pre Dispatch Inspection Report).
• Manage COA documentation and Audits.
• Supervise Packaging as per Customer requirement including maintaining inventory & stock of all packing material for the CleanRoom such as Labels, marking material, poly bags, pouches, cleaning material etc.
• Ensure routine maintenance/ AMC of all the equipment/ machinery in CleanRoom.
• Candidates with global exposure of New Product Innovations with–USA, Europe, Middle east, APAC markets will be preferred.
• Manage cleanroom operations involving resource planning, material planning, in-process inspection, and team building.
• co-ordination with internal departments & external customers Effective
• communicator with excellent relationship manage.

Desired Candidate Profile

• Bachelors/Master’s degree in Mechanical Engineering/ Bio-Sciences.
• 5+ year Cleanroom work experience from Medical Devices Industry.
• Adept in managing operations involving resource planning, materials planning, in-process inspection, team building, and co-ordination with internal & external customers Effectively.
• Must be familiar with ISO 13485 and ISO 14971Internal Audit Requirements.
• Superb ability to effectively communicate with staff members across the organization.
• Excellent computer and internet search skills.
• Strong ability to multi-task and to meet business deadlines.
• Experience in Packaging project transfer.
• Experience in Cleaning validation and Biocompatibility studies.