Process Development Associate Engineer I, Fill & Finish (Biotechnology)

Location: Cape Town, South Africa; on-site. Applicants must be South African or already eligible to work in South Africa with the necessary work permits or visas.

Application deadline: Friday, 9 October 2026, although the position may close earlier.

Company

hirify.global is a life sciences company developing genomics, molecular diagnostics, and personalised medicine products through enzyme engineering and computational biology.

What you will do

• Design and transfer reagent filling and assembly processes from R&D to manufacturing.
• Identify critical process parameters and connect them to critical-to-quality attributes.
• Develop, adapt, and experimentally validate scalable processes, equipment, controls, and materials.
• Support process, equipment, and computer system validation, process capability analysis, and risk mitigation.
• Investigate process issues in on-market products through data trending, analysis, and experimentation.
• Create work instructions, batch record templates, training materials, and deliver operator training.

Requirements

• BSc or BEng in Process or Chemical Engineering with 0–2+ years of relevant experience in process engineering or biotechnology.
• Alternatively, an MSc in molecular biology, enzymology, or a related field with 2+ years of industry experience in process development.
• Strong systems thinking, critical thinking, problem-solving, organizational, communication, and interpersonal skills.
• Ability to work effectively in cross-functional teams and communicate technical information to varied scientific audiences.
• Working understanding of ISO 13485 and standard operating procedures.
• Eligibility to work in South Africa and the required work permits or visas are mandatory.

Nice to have

• Knowledge of PCR, next-generation sequencing, and basic protein biochemistry.
• Experience with life science reagent manufacturing, finished goods manufacturing, or scale-up.
• Experience with MSA, Gauge R&R, DOE, SPC, regression analysis, ANOVA, or t-tests.
• Experience with FMEA, risk management, ISO 9001, or quality management systems.

Culture & Benefits

• Collaborative work across R&D, Production, IT, and Quality Assurance teams at global sites.
• Work in a culture focused on innovation, scientific rigour, continuous improvement, and operational excellence.
• 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 legally applicable.

Hiring process

• Submit a PDF letter of motivation and resume or curriculum vitae.
• Selected candidates will provide three professional references and a current payslip.
• Applications without a letter of motivation will not be considered.