Validation Specialist

Biovac; Cape Town; On-site; ZAR 600 000 - 750 000; Full time

Job summary

A leading vaccine manufacturer in Cape Town seeks a Validation Specialist to ensure compliance with regulatory standards and mentor team members. The ideal candidate will have a degree in a relevant field and at least 5 years of experience in qualification and validation within the pharmaceutical industry. This role is critical for maintaining the integrity of the validation process, providing guidance on qualification activities, and supporting the Validation Manager with departmental goals.

Qualifications

• At least 5 years' experience in Qualification and/or Validation.
• Experience in quality management systems within a cGMP facility.
• Experience in quality and regulatory compliance within a cGMP facility.

Responsibilities

• Provide guidance on qualification and validation activities.
• Support team members with mentorship.
• Ensure compliance with regulatory requirements for validation documentation.

Skills

Guidance on qualification and validation activities

Mentorship for team members

Knowledge in cGMP compliance

Risk management

Strong communication skills

Education

Degree or diploma in Engineering/Chemistry/Natural Sciences/Microbiology/Computer Science/Information Technology/Information Systems/Automation

Job description

BIOVAC is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and meticulous Validation Specialist to join a goal-oriented team.

QUALIFICATIONS NEEDED

• Degree or diploma in Engineering / Chemistry/ Natural Sciences / Microbiology/ Computer Science / Information Technology/ Information Systems/ Automation or related discipline.

NECESSARY EXPERIENCE & INDUSTRY KNOWLEDGE

• At least 5 years' experience in the field of Qualification and/or Validation within a sterile pharmaceutical/ biotech manufacturing industry.
• Experience in quality management systems within a cGMP facility.
• Experience in quality and regulatory compliance within a cGMP facility.
• Knowledge in business and operational planning.

KEY DUTIES & RESPONSIBILITIES OF THE ROLE

Core Technical Delivery

• Accountable for providing guidance on qualification and validation activities.
• Provide mentorship to support team members.
• Ensure that Qualification and Validation requirements are achieved at the required quality and regulatory levels (Biovac, SAHPRA, WHO, pharmacopoeia) and within the agreed timeframes.
• Provide guidance and perform technical reviews of all Qualification and Validation-related documentation generated by the team.
• Ensure that all generated validation documentation are reviewed, approved, signed off, tracked and expedited as required.
• Report/Escalate timeously on Qualification and Validation activity progress, status and blocking points to the Validation Manager.
• Identify and report any potential risks associated to Qualification and Validation activities.
• Ensure operational functioning of each section to meet KPIs and validation schedule.
• Ensure that the team and its respective sections deliver services and solutions in alignment with pharmaceutical quality system requirements and budgetary allowances.
• Liaising with internal and external service providers.
• Define Process Development activities including Process Validation, Aseptic Process Simulation, Cleaning Validation and Cold Chain including the associated strategy.
• Ensure execution of all validation activities according to the defined schedules.
• Define qualification approaches to new equipment for site.
• Ensure execution of Qualification processes.
• Assist equipment owners with identifying maintenance and calibration requirements.
• Participate in and lead troubleshooting discussions to investigate a wide range of challenges which require creative thinking.
• Validation administration such as updating the validation plan, maintaining schedules, standard referencing of documentation.
• Participates in troubleshooting a wide range of problems which require creative thinking.
• Exercises significant technical discretion in design, execution, and interpretation, and pursues new validation studies as a result of experimental outcomes.
• Define general activities and the associated strategy related to assigned areas of specialty.
• Ensure execution of all activities according to the defined schedules.
• Communicate the status of validation to the business on a regular basis.
• Communicate any delays/ issues/ changes experienced during qualification and validation task execution.
• Communicate with departments related validation planning and time needed on validation activities.
• Provide guidance to staff from other departments related to the required content of procedures.
• Manage internal customer relations and communication.
• Communicate any delays/ issues/ changes experienced during task execution.
• Communicate with departments related to activity planning and allocate timelines.Identify quality risks in the section and initiate risk management where required, e.g. to support investigation or choices.
• Provides scientific input into problems and new initiatives to ensure that a science & risk-based approach is adoptive to support.
• Ensure that SOPs, VMPs and documents are up to date with the latest pharmaceutical and best practice guidelines.
• Ensure Deviations, Incidents, Change Controls, CAPAs, audit findings, QRAs for the sections are handled effectively.
• Ensure that the validation schedule is in place, communicated, updated and delivered according to defined timelines.
• Ensure development and training plans are implemented for staff.
• Support the Validation manager with team strategy and department goals setting.
• Oversight of all validation & qualification activities performed by external stakeholders according to defined schedules.
• Lead significant investigations linked to validation and Qualification activities.

Application Deadline: 22 November 2025

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.