Manufacturing Operative 2

4 weeks 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. We have served the global diagnostics industry for over 50 years and due to our continued growth, we are seeking an Enzymes Technical Leader to join our team. This is a permanent, full time position based at our facility in Cape Town.**

**Role Overview**

As a Manufacturing Operator 2 you will work alongside the wider production team and
follow rigid procedures in the manufacturing process. Records information related to manufacturing process and process times. Ensures the manufacturing equipment is cared for and maintained. Reports all damage or defects and complete non-conformance forms. Keeps production area clean, neat and tidy, free from any debris in compliance with cGMP. Participate in stock take, capturing & ordering of stock. Required to train other operators & be trained on all Production equipment and process stages from Extraction to F/Dry. Required to be trained as a first aider, health & safety representative or fire fighter. Operate a forklift to assist with movement of material. Responsible for calibration of process equipment (ph, conductivity & temperature meters & scale). Will be required to conduct product release in absence of the Team Leader or Production Technician. Must be able to work extended hours, weekends or night shift if required due to operational requirements.

**Experience in a relevant industry or scientific qualifications are desirable but are not essential for you to succeed in this role.

**Role Requirements**

Key responsibilities will include but are not limited to:
**Role Specific**
- Follow working instructions to operate any Production related equipment for the particular process.
- Able to process any Product line secondary process from start to post Freeze dry packing, includes column chromatography following an approved processing batch record.
- Able to lift 25 kg bags using the correct lifting technique or two-person lift.
- Prepare any process buffer following prescribed work instruction to achieve the desired normality and pH
- Train other operators & receive training on all Production process stages from Extraction to F/Dry.
- Complete batch records as per process in a 100% accurate & timely fashion, 100% compliance to BBI & ISO Quality standards.
- Clean equipment and work area as per cleaning procedures & to GMP standards & adherence to microbial swab requirements per month.
- Capture hours & material spent on process onto the ERP System, 100% accuracy.
- Interpretation of QC Data & completion of 2 logbooks daily or monthly.
- Comply with documented process & work instructions.
- Completion of MBR’s to be 100% daily, ALCOA, post a process stage
- Requisitions of good from the stores when required.
- On time in full delivery (OTIF) to internal customers
- Identifying Process Improvements & assist with process problem solving, understanding W+H; 5WHY’s and Cause and Effect diagram.
- Initiation of Non-conformances & completion of forms on Q-Pulse
- Online problem-solving adjustments of pH, recalibrate fractionation percentage, reprocessing of a product to achieve a critical parameter.
- Participation in problem solving, improvement (5-S) & cost saving projects.
- Conduct self-audits of various Production areas or procedures.
- Complete assessments and update training matrix accordingly.
- Personal Development: Willing to be trained on In-process control analysis (A280, RZ & Activity), autonomous maintenance, production planning, product releases, leadership & mentorship.

**About The BBI Group**

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.

BBI Solutions is part of the BBI Group.

**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 people are our strength, we offer an attractive benefits package to our employees:
Provident Fund
% Contributory Retirement Scheme
Death in Service Insurance
Disability Insurance
Private Healthcare Scheme
15 days Annual Leave, which increases by 1 day per annum to 20 days
Birthday leave
Long Service Awards
Global Employee Wellbeing Progra



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