Job ID :
New Zealand - Auckland
- Perform manufacturing and assembly of Class 1 medical device cell culture products in accordance to current good manufacturing practices.
- Operate semi-automated and automated manufacturing equipment.
- Weigh, measure and check raw materials to assure batches manufactured contain proper materials and quantities.
- Maintain records to comply with regulatory requirements, GMP’s and standard operating procedures.
- Perform in-process testing to assure batches meet specification.
- Maintain equipment and rooms in proper operation condition and proper cleanliness requirements.
- Perform activities in controlled environment up to and including classified clean room conditions.
- May be required to perform other related duties as required and/or assigned.
- Understand and accept that this position requires full hands on practical involvement and application in all respects of the manufacturing task.
- Be involved in the continuous improvement of our Quality Systems and maintain and enhance our cGMP culture. This may include, but is not limited to revising, updating and amending of relevant Standard Operating Procedures and Batch Manufacturing Records as required by Company and Industry standards.
- Maintain up to date training records of tasks you have demonstrated competence in.
- Maintain good liaison with the Technician’s, Team Leaders and Supervisors concerning manufacturing schedules and requirements.
- Accept responsibility in the areas of inventory control, material purchasing, manufacturing schedules and task execution including final packaging, documentation and data requirements for the product/s delegated by the Team Leaders or Supervisors.
- Good understanding of both the theoretical and practical aspects of separation techniques like centrifuge operation and separator operation.
- Maintain excellent manufacturing records and to follow Standard Operating Procedures (SOP’s) at all times.
- Assist in the maintenance of relevant manufacturing areas to an excellent standard of cleanliness, tidiness and maintenance.
- Assist in the maintenance of accurate stock records and movement
- Carry out any reasonable task that is requested of you in the Production departments.
Experience and Education
- A minimum of 1 years experience in a GMP manufacturing environment is desireable. Knowledge of computer applications and current software is desirable. General understanding of machinery and mechanics is advantageous.
- Academic qualifications to sixth form certificate, in Chemistry, Mathematics, and Biology, or a tertiary qualification primarily in a biological science is preferred.
- To be naturally self-motivated towards achieving high quality results.
- An ability to work unsupervised in a safe manner is essential.
- Physical fitness, comfortable of lifting weights up to 20kg on a routine basis, and having no allergic reaction to alcohol or chlorine based sanitizers.
- An ability to solve problems in a practical and analytical manner.
- A high standard of communication skills, both oral and written, are essential.
- Knowledge of computers would be an advantage.
- Honesty, responsibility and reliability (including accurate time keeping) are sought after attributes.
- Possess a strong desire to work with people in a team situation and environment.
- Hold a current driver’s license.