Overview
The Technician supports the operation of a biomanufacturing facility by performing routine and specialised production tasks to manufacture products in compliance with Good Manufacturing Practices (GMP) and safety regulations.
This role involves operating and maintaining production equipment, monitoring process parameters, recording data, and performing inprocess quality checks to ensure consistent product quality and batch integrity.
Reports to
Manufacturing Team Lead
Consults with
Quality Control (QC); Engineering & Maintenance; Supply Chain/Materials; Management; EHS Management
Level of Responsibility
Operates within clearly defined SOPs and work instructions under close to moderate supervision.
Responsible for product quality during assigned production stages.
Required to report deviations, defects, or equipment issues immediately.
May assist with training of new operators.
Responsibilities
Operate and maintain production equipment
Monitor process parameters
Record data and perform inprocess quality checks to ensure consistent product quality and batch integrity
Report deviations, defects, or equipment issues immediately
Assist with training of new operators
Qualifications
Experience in GMP or regulated manufacturing preferred.
Leaving Certificate or equivalent required; postsecondary technical training preferred.
GMP training certification advantageous.
Basic mechanical aptitude and familiarity with manufacturing environments desirable.
Strong attention to detail and product safety awareness.
Work Experience
0-2 years' experience in manufacturing, packaging, or assembly
Experience working in a GMP or ISOregulated environment is an advantage.
Prior cleanroom or sterile assembly experience beneficial.
Knowledge, Skills & Abilities
Knowledge of GMP, GDP (Good Documentation Practices), and basic regulatory requirements
Cleanroom classifications, gowning, and contamination control principles
Standard manufacturing and assembly processes in a regulated environment
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