As BIOVAC expands its manufacturing base it will embark on a large facility expansion project in Cape Town spanning over the next 10 years. The project is distributed over several phases and aims to build and expand on Biovac s sterile manufacturing capability in vaccines across the full value chain. To facilitate this Biovac is looking for exceptional project skills and expertise in a range of disciplines within sterile pharmaceutical manufacturing. We are looking to hire a dynamic, passionate, confident, proactive and meticulous Senior Process Lead (Projects) to join a goal orient.
QUALIFICATIONS NEEDED:
- Bachelors or higher degree in chemistry/biotechnology/pharmacy/chemical engineering or equivalent.
NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE:
- Good working knowledge of aseptic (sterile) manufacturing processes.
- At least 10 years of process, equipment and project design and execution experience within the sterile pharmaceutical /biotech manufacturing industry.
- Experience in managing and executing multi-disciplinary projects in excess of R100 million.
- Excellent understanding of process flows and key metrics within a sterile manufacturing environment.
- Excellent understanding of the cGMP guideline relating to sterile products.
- Experience in initiating, planning, executing, and closing projects.
- Experience in, the control and monitoring of project progress and risks.
KEY DUTIES & RESPONSIBILITIES OF THE ROLE:
- Ensures that projects are properly scoped with clearly defined deliverables and clear execution plans.
- To execute the full range of technical project activities including design, scoping, budgeting, scheduling and execution for successful delivery in line with organizational requirements.
- To develop technical standards and user requirement specifications.
- Identify and escalate risks and mitigation/recovery plans.
- Create project budget and ensure adherence to the prescribed budget.
- Request approval for changes from necessary stakeholders and manage changes via project change request processes.
- Ensure that the quality criteria are properly defined for each deliverable and frequently measured and reported.
- Ensuring all designs are cost effective and value adding for Biovac.
- Execute/provide technical advice for process and/or equipment processes.
- Conduct manufacturer visits to perform design reviews, risk analysis, FAT as well as receive training from manufacture for the relevant equipment.
- Compile the necessary documentation upon completion of manufacturer visit and training.
- Conduct the necessary research in order to contribute towards ensuring that the process equipment (new equipment) is qualified (IQ, OQ) and ready for production activities within the project timelines.
- Process equipment SOPs, specifications, qualification documents and MBRs are generated through the appropriate review process and in place for production within the required timeline.
- Ensures that the project delivery is in line with agreed Sterile Products cGMP guidelines.
- Ensures process design meets quality criteria.
Application Deadline: 29 August 2025
If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful.
We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.
Disclaimer:
Dear Applicant, we appreciate your interest in joining our organization. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.
