Pharma Cleanroom Production Technician

Emergent BioSolutions, Inc.; Winnipeg; On-site; CAD 19,000 - 28,000; Full time

Benefits offered by this job

Extensive benefits package

Flexible work arrangements

Job summary

Emergent BioSolutions, Inc. in Winnipeg, MB, is seeking a Cleaning/Maintenance Associate to support pharmaceutical production by maintaining the cleanroom environment and keeping records to comply with cGMP, SOPs, and regulatory requirements.

You will perform routine and emergency cleaning of equipment and rooms, report issues, support transfers, manage waste, operate sampling equipment, and assist with validation, maintenance, and QA activities as needed.

Qualifications

• A high school diploma or equivalent level of education is required.
• A Certificate in Pharmaceutical and Food Manufacturing from a recognized institution or previous pharmaceutical manufacturing experience would be considered an asset.
• 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 work on ladders, stairs, or at heights when required.
• Ability to safely work with material handling equipment such as portable tanks, skids, EM sampling equipment.
• 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.
• Ability to lift up to 50lbs.
• Successful completion of the pre Employment Medical and security clearance is required.

Responsibilities

• Perform routine and emergency cleaning of manufacturing equipment, cleanrooms, and support areas.
• Report equipment, facility, or safety issues.
• Support receiving, cleaning, and transfer of manufacturing tanks and equipment.
• Restock production areas and maintain cleanliness of classified and non-classified areas.
• Operate and maintain non-viable particulate (NVP) machine and SAS air sampler and perform Viable sampling using contact plates for cleanrooms.
• Perform and support validation, maintenance, engineering, and quality activities when required.
• Use Lab Vantage LIMS for sampling processes.
• 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 inventory of cleaning supplies, disinfectants and consumables.
• Execute equipment changeovers and move equipment in and out of cleanrooms.
• Collect, transport, and manage waste, including biohazardous waste.
• Document and complete GMP documentation, logbooks, cleaning logs, and work orders.
• Use SAP ERP system to perform cycle driven and unscheduled work orders for filter replacement, cleaning of freezers, coolers and incubators.
• Follow GMP, safety, environmental, and company procedures at all times.
• Perform other duties as assigned.

Skills

Communication

Multi-tasking

Teamwork

Lift heavy objects

SOP adherence

Shift flexibility

Safety awareness

Reading SOPs

Education

High school diploma or equivalent

Certificate in Pharmaceutical & Food Manufacturing

Tools

Microsoft Office (Word, Excel)

Lab Vantage LIMS

SAP ERP system

Job description

Emergent BioSolutions, Inc. in Winnipeg, MB, is seeking a Cleaning/Maintenance Associate to support pharmaceutical production by maintaining the cleanroom environment and keeping records to comply with cGMP, SOPs, and regulatory requirements.

You will perform routine and emergency cleaning of equipment and rooms, report issues, support transfers, manage waste, operate sampling equipment, and assist with validation, maintenance, and QA activities as needed.