Learn & perform well-defined procedures
Pursue ongoing training to increase knowledge & understanding
Attain basic understanding of cGMP requirements & compliance within a GMP manufacturing setting
Perform assigned tasks (by Section Lead/ Manager) both with and without supervision
Perform equipment monitoring & and basic 6S housekeeping
Perform basic laboratory tasks (e.g. sampling, pH/ conductivity/ osmolality measurements etc.)
Perform routine sanitization tasks to maintain facility standards
Achieve & consistently maintain a training status of ≥ 90%
100% trained & signed off on Performance Measures (PMs) relating to CIP/ SIP/ basic tank & instrument operations
Demonstrate aseptic technique in the handling of product/ materials
Technical Process Expertise
Exhibit basic understanding of critical process/ operational parameters and target/ acceptable ranges
Problem Analysis/ Decision Making
Make basic decisions e.g. know when to seek help & who to contact
Identify situations which may require further escalation to Section Lead/ Manager
Organize & plan assigned daily activities to ensure timely completion of all assignments
Document all work as it occurs
Ensure all BRs related materials e.g. dispensings, consumables, traceables, cleaned/ autoclaved parts etc are available in advance of scheduled usage
Ensure all equipment are ready for production use (i.e. within CIP/ SIP expiries) in advance of scheduled usage
Communicate to a level where appropriate questions are asked to increase understanding of role
Report to Section Lead/ Manager
Receive daily supervision on routine work & detailed instructions on new assignments
Preferably with at least 2 years of relevant work experience in a similar industry
Degree/ Diploma/NITEC in a related Science/Engineering discipline
Knowledge of Biopharmaceutical processing is an added asset
Knowledge of cGMP applications
Positive team oriented attitude
Strong communication and interpersonal skills
Willing to perform rotating 12-hour shift pattern
All Lonza Biologics Employees have the following responsibilities:
Quality should be the responsibility of all persons involved in Manufacturing. Adherence to cGMPs is required at all times during the manufacture of APIs.
All personnel are responsible for notifying responsible Management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc.)
All personnel should practice good sanitation and health habits.
Personnel suffering from an infectious disease or having open lesions on the exposed surface of the body should not engage in activities that could result in compromising the quality of APIs.
All personnel are required to provide support in maintaining the site safety, health and environmental programs and system.
Adherence to SHE rules and regulations is required at all times.