Senior Microbiologist will perform environmental testing and reporting, conduct investigations, work with quality regulations and guidelines, assess necessary lab adjustments, perform risk assessments, and ensure compliance in the Microbiology lab.
- Assesses changes to cleanroom environments by supporting the Equipment Transfer Plan program.
- Supports laboratory testing including, but not limited to, bacterial gram staining, growth promotion, microbial identification, bacterial endotoxin testing, bioburden recovery, and sterility testing.
- Coordinates and supports facility, equipment, and HVAC maintenance events between multiple departments.
- Maintains regulatory compliance of the sterilization program for sterile implantable devices by performing process re-qualifications, new product qualifications, and risk assessments.
- Coordinates testing with contract laboratories (scheduling, submitting samples, reviewing results, conducting investigations, creating, and maintaining Purchase Orders)
- Supports environmental particulate and microbial testing for ISO certified cleanrooms, Heating Ventilation & Air Conditioning (HVAC) systems, Compressed Air Gas Systems, and Pharmaceutical Grade Water Systems.
- Ensures regulatory compliance of product and material biocompatibility by performing safety assessments and testing for sterile implantable medical devices to support existing product and/or process changes and new products.
- Performs risk assessments for deviations, OOS events, CAPAs, NCMRs, and COPs.
- Performs risk assessments for changes related to manufacturing process changes, product development, material biocompatibility, and product changes.
- Develops equipment, product, and process cleaning and disinfection validations.
- Creates Experimental Requests to support special studies and projects.
- Develops test method validations in support of microbiology operations.
- Develops, generates, and supports Performance Qualification and Validation protocols and reports.
- Supports all tasks related to laboratory upkeeping and the environmental monitoring program.
- Experience with pro-longed contact and permanent implantable devices
- Microbiology, Biology, or equivalent Bachelor’s degree (B.A./B.S)
- Experience in maintaining, supporting, and developing test methods for sterilization of medical devices and biocompatibility testing.
- 3+ years industry experience
- Knowledge of the following standards and regulations: 21 CFR 820, ISO 13485, CMDR, and EEC93/42, US and EU Pharmacopeia <85>, <161>,
- AAMI/TIR 30, AAMI/TIR 52, International Organization for Standardization (ISO) 10993, 14644, 11137, 11737, 14971, and other risk guidance standards
- Experience in monitoring of environmental systems (HVAC, Cleanroom, Compressed Air, Compressed Gases, Water)
Vacancy Type: Full Time
Job Location: Simpang Ampat, Penang, Malaysia
Application Deadline: N/A