Facilities Production Technician

Emergent Biosolutions•Winnipeg, MB

1d•Onsite

About The Position

Supports the production of pharmaceutical products according to schedule through the maintenance of the clean room environment and associated records to comply with regulatory requirements, current good manufacturing practices (cGMP), and standard operating procedures.

Requirements

A high school diploma or equivalent level of education is required.
Basic knowledge of Microsoft Office – Word, Excel.
Able to multi-task and adapt to changing priorities.
Able to communicate and articulate information accurately in both written and verbal forms.
This role requires the removal of jewelry as per cleanroom gowning requirements.
Ability to lift and move materials/equipment when needed.
Able to work on ladders or at heights when required.
Ability to read, understand, and follow standard operating procedures, protocols, work instructions, and other policies/procedures is required.
Demonstrate good work ethic and ability to work alone or in a group setting.
Abiltiy and flexibility to adapt and complete shift work including days, evenings and weekends.
Ability to pass pre-employment medical and background check.

Nice To Haves

A Certificate in Pharmaceutical and Food Manufacturing from a recognized institution or previous pharmaceutical manufacturing experience would be considered an asset.

Responsibilities

Follow all written procedures according to GMP standards.
Operate and maintain non-viable particulate (NVP) machine and SAS air sampler and perform Viable sampling using contact plates for cleanrooms.
Perform Protocol execution for various validation studies for cleanroom areas and equipment.
Use Lab Vantage LIMS for all routine and non-routine sampling processes (sample collection and submission to labs).
Perform compressed gas sampling using MAS-100 unit (portable air sampler).
Prepare Decon-Quat disinfectant solution.
Wash and sanitize sampling materials and wrap in sterilization wrap for autoclave.
Operate filter integrity testers to confirm integrity of the cleanroom filters
Maintain the inventory of consumables in the cleanrooms.
Assist with equipment movement and setup to facilitate the changeout process.
Assist in waste decontamination of Biohazardous waste from clean rooms
Document all activities in appropriate controlled cleaning logs (review, reconcile, file)
Use SAP ERP system to perform cycle driven and unscheduled work orders for filter replacement, cleaning of freezers, coolers and incubators
Responsible for disinfecting clean rooms on daily basis as per the cleaning log requirements
Perform other duties as assigned.