Freeze Drier and Cgmp Area Technician

1 week ago

Cape Town, South Africa BBI Group Full time

**The BBI Group aim to create a world where everyone has the opportunity for a better quality of life. **Due to our continued growth, we are seeking a Freeze Drier and cGMP area Technician to join our Facilities / Maintenance team. This is a permanent, full
- time position based at our facility in Cape Town.**

**About BBI Solutions**

Our range of immuno-diagnostics reagents includes human antigens, antibodies, enzymes and serum & plasma products. With manufacturing sites spanning four continents, we produce world-renowned labels for lateral flow, ELISA assay and biosensors, including our high-quality gold nanoparticles and glucose oxidase. The acquisition of German-based DIARECT AG in June 2020 established BBI as the leading provider of antigens in the autoimmune and tick-borne IVD markets.

**Role Overview**
- The Freeze Drier and cGMP area Maintenance Technician will work within the Maintenance service delivery department and company framework to ensure the effective maintenance of all process and service related equipment.
- As a qualified Mechanical / Electrical / Refrigeration Technician, the bulk of the work will be related to services maintenance of plant and equipment, however i the role of FD and cGMP Area Technician will be required to carry out maintenance services as and when required in the preventative maintenance and break down job card system in the following areas:

- Freeze Driers and associated refrigeration equipment and control systems
- Cooling water systems, Chillers and Cooling Towers
- RO-water Systems
- cGMP Area (Ovine Primary, Secondary & Dispensary)
- cGMP Area (Freeze Dryer Facilities)
- Area instrument calibration compliance
- As a qualified artisan/technician the incumbent will be required to complete and maintain various records related to statutory requirements as well as internal documentation.
- The appointed artisan will also be on standby and required to work after hours as and when required.
- Will be required to be trained as First Aider, Health& Safety Rep or Fire Fighter.
- Keeps work areas in neat order.
- Assists the line manager with stock keeping, record keeping and training of contractors and personnel.
- Will also be required to be trained on cGMP practices and regulations.
- You will be required to work in all areas of the company from production to service delivery

**Role Requirements**

**Qualifications and Experience**
- Technically qualified and trade tested.

**Key Skills Required**
- Fault finding and repairs
- Good organizational skills.
- Reliable, tolerant and self-driven.
- Good interpersonal skills.
- Communication skills.
- Computer literate - MS word, Excel, Access, Projects.
- English writing skills with Good Ducumenttaion Practices

**Key responsibilities will include but are not limited to**:

- Corrective & Preventative maintenance program recording and completion.
- Implementation of preventative and or corrective measures.
- Contribute to plant availability of at least 95.5%.
- Drill down to technical aspects of field of specialty.
- Participation in problem solving, improvement and or cost saving projects/initiatives.
- Follow work instructions relating to the QMS system.
- Adherence to cGMP policies and procedures
- Raise requisitions on ERP Financial system for purchasing/ordering requirements.
- On time and in full delivery to internal customers.
- Capture hours and work performed on various tasks in detail and with 100% accuracy on DMS job cards.
- Identify improvements & assist in implementation.
- Initiation of non-conformances, SQA’s & completion of forms.
- Train contractors/fellow employees on permit systems and or equipment usage.
- Personal development: Willing to be trained on various processes within BBI and also external training and development relating to job function.
- Required to be trained and self-develop on automation projects and electronic use of tablets for record keeping and or reporting.
- Will be required to be trained as First Aider, Health & Safety Rep or Fire Fighter.
- Keeps work areas in neat order.
- 3 to 5 years’ working experience in a mechanical / electrical / refrigeration technician role
- Knowledge of GMP and ISO requirements
- Experience working in a cGMP environment would be advantageous
- Experience with freeze dry and refrigeration maintenance will be a preferred
- To assist line manager with stock keeping, record keeping and training of contractors and personnel

**Benefits**
*
*
Here at BBI, we are committed to promoting and protecting the physical and mental health and well-being of all our employees. They play a pivotal role in improving the quality of people’s lives and are focused on delivering exceptional products and technologies. With our employees focused on others, we’re focused on them. That’s why, at BBI, we’re dedicated to providing our employees with access to global resources and site
- specific benefits that support their health and wellbeing.

Recognising that our

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