Website The Biovac Institute
The Biovac Institute requires a Machine Operator to contribute to its mission of establishing local biological and vaccine manufacturing capability at its Cape Town based site. Being the only one of its kind in South Africa, Biovac strives to respond to the vaccine needs of the developing countries, specifically South Africa and Sub Saharan Africa. This is a particularly exciting time for the company as it continues to grow, strengthen and build on its success and further develop its capabilities, products, services and market diversification.
The successful incumbent will report to the Production Supervisor.
Key Areas of Responsibility:
- Execution of the manual and automated visual inspection, labelling and packing activities at the required quality levels as per plan.
- Identify potential problem areas, ensuring early detection or diagnosis and implementation of solutions for production equipment.
- Ensure wastage of materials and components are within departmental expectations.
- Ensure that all components necessary for daily running of the machines in VLP are adequately stocked at all times
- Ensure that regulatory and statutory requirements are met according to cGMP and GdocP
- Strict adherence to SOP instructions at all times.
- Ensure that waste disposal processes of product and components are strictly adhered to and reported
- Maintain a healthy and safe work environment
- Must be able to assist with or lead investigations pertaining to deviations related to production equipment.
- Set up machines at the beginning of each day/shift to ensure proper working order
- Perform testing procedures/calibrations to ensure that machines function optimally during production procedures
- Prepare the required process steps (materials, waste), equipment and process space in time to not hold up planned production activities/schedules
- Oversee and run machines during daily production activities.
- Make basic software changes on the computer interface/HMI.
- Write machine operation SOPs and Work Instructions according to the company’s templates and policies
- Perform required mathematical calculations to run the machines effectively
- Conduct visual inspection, labelling and packing activities
- Maintain all equipment related paperwork and reports, including HMI and computer and or printer interface
- Knowledge of Pharmaceutical Industry Standards and Guidelines in GMP and Quality Systems
- Current GMP knowledge and Understanding
- Standard Operating Procedures
- EHS Legislation and basic knowledge applicable to function
- Technical Machinery / System Knowledge
- Sound Technical Report Writing Capabilities
- Proficient in Microsoft Office
- Sound Numerical Literacy
- cGMP vaccine manufacturing- quality and Regulatory Compliance Knowledge, i.e. MCC and WHO
- Quality management Systems
- Analytical thinking
- Planning skills
- Communication skills (verbal & written)
- Time Management Skills
- Strong detail and compliance orientation
Education and experience required:
- 3 – 4 yrs. previous experience in a Technical / Mechanical Machine Operator Position in Brevetti and Seidenader Automated Visual Inspection Systems.
- 3-4 yrs. previous experience in Automated Packing Lines.
- Experience in Thermoforming systems with sound problem solving capability.
- Experience in the Vaccine/ Biotechnology, Food or Pharmaceutical Industry in a related Technical position
- Knowledge of a Sterile Manufacturing or Pharmaceutical Environment
- Proficient MS Office Knowledge
- Mechanical / Electrical Engineering N3 Qualification Certificate or Higher with a Computer Literacy certification.
All positions will be filled in accordance with our Employment Equity policy as The Biovac Institute is committed to the pursuit of excellence, diversity and redress. If you are interested in applying for this position, kindly forward your application onto firstname.lastname@example.org by close of business on 30 May 2018.
Kindly note that by submitting your application for this career opportunity you agree that Biovac may use your application for the purpose of the recruitment and selection of the said position and this information may be shared with the relevant stakeholders in the business