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4 дня назад

Process Development Associate (Formulations)

Формат работы
onsite
Тип работы
fulltime
Грейд
junior
Английский
b2
Страна
SA
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Process Development Associate (Formulations) (Biotechnology): Designing and transferring scalable reagent manufacturing processes with an accent on critical process parameters, validation, experimentation, and process documentation. Focus on identifying process risks, applying statistical methods, supporting quality systems, and training operators on reproducible procedures.

Location: Cape Town, South Africa; on-site. Local candidates are preferred.

Company

hirify.global develops enzyme-engineered and computational biology products for genomics, molecular diagnostics, and personalised medicine, with R&D and production facilities in Cape Town and headquarters in Boulder.

What you will do

  • Design, adapt, scale, and transfer reagent manufacturing processes from R&D to production.
  • Identify critical process parameters and critical-to-quality attributes through experimentation.
  • Support process, equipment, and computer system validation, material qualification, and process capability assessment.
  • Plan project deliverables, document experiments, investigate process risks, and develop mitigations.
  • Support launched products through data trending, analysis, and investigation of process-related issues.
  • Author production documentation and train operators on new or revised procedures.

Requirements

  • BSc or BEng in Process or Chemical Engineering with 0–2+ years of relevant experience in process engineering or biotechnology, or an MSc in molecular biology, enzymology, or a related field with 2+ years of demonstrated industry experience in process development.
  • Systems-level thinking and the ability to design robust, scalable reagent manufacturing processes.
  • Strong scientific, written, verbal, organizational, interpersonal, critical-thinking, and problem-solving skills.
  • Ability to work effectively in cross-functional teams and manage projects with a high level of self-motivation and attention to detail.
  • Working understanding of ISO 13485 and standard operating procedures.
  • Applicants must currently be eligible to work in South Africa and must disclose whether visa sponsorship may be required.

Nice to have

  • Experience with PCR, next-generation sequencing, protein biochemistry, or mid-scale life science reagent manufacturing.
  • Knowledge of measurement systems analysis, Gauge R&R, Design of Experiments, Statistical Process Control, regression, ANOVA, or t-tests.
  • Experience with FMEA, hazard analysis, ISO 9001, ISO 13485, or structured quality management systems.

Culture & Benefits

  • Collaborative work across R&D, Production, IT, and Quality Assurance teams at global sites.
  • Work in an environment focused on innovation, scientific rigour, continuous improvement, and product quality.
  • Equal opportunity and affirmative action employer committed to a culturally diverse workplace.
  • Pre-employment checks may include driving history, drug screening, and background checks where permitted by law.

Hiring process

  • Submit a PDF containing a motivation letter and resume or curriculum vitae; applications without a motivation letter will not be considered.
  • Three professional references may be requested during the interview process.
  • Applications should be submitted by 23 October 2026, although the position may close earlier.

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