Validation Scientist

Quality Assurance Operations Department

Pinelands, Cape Town

The Biovac Institute requires a Validation Scientist 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 Qualifications Section Head.

The Key Performance Areas for this position include:

• Qualification System Maintenance

• • Ensure that the qualification systems, procedures and test methods are up to date and meet internationally accepted standards and GMP expectations.
  • Ensure that service providers are contracted to provide the correct testing services
  • Ensure that stakeholders are appropriately informed or trained
• Routine qualification Services
• • Ensure that routine qualification activities are coordinated with production, maintenance, calibration and other stakeholder activities.
  • Ensure that customers and stakeholders are informed of and engaged in planned activities
  • Ensure all allocated activities are performed ahead of due date
  • Address any identified issues with customers and ensure that sustainable solutions are documented and implemented

• Participate efficiently and creatively in planning of implementation objectives and timelines with stakeholders and managers.
• Efficient study design, consultation and protocol generation and signoff processes.
• Efficient implementation, report generation and resolution of issues raised.

• System improvements and capacity building

o  Contribute technical knowledge, experience and learnings to qualification and validation activities and planning.

o   Ensure that a qualified or validated state is maintained and that the proof of this is fully documented

Qualifications and Skills Required:

• Degree or diploma in Engineering or related subject or equivalent extensive experience
• Aseptic Manufacturing experience would be an advantage
• Three years’ experience in e.g. vaccine / biotech / parenteral pharmaceutical industry or equivalent would be advantageous
• Quality & regulatory compliance knowledge, i.e. MCC and WHO would be an advantage.
• Experience in having faced successfully local quality audits would be an advantage.
• Qualifying, validating and re-assessing pharmaceutical facilities, utilities, equipment, computer systems or processes.
• Knowledge of the standards and test methods for such functional testing and experience of testing Grade A and B clean room environments would be highly advantageous.
• Generation of qualification or validation protocols. 
• Involvement in formal Risk Management processes

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. We encourage those living with disabilities to apply.

Interested persons to kindly submit their CV’s to recruitment@biovacinstitute.co.za

Kindly note that only successful candidates will be contacted within 3 weeks of application