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Watchmaker Genomics, a global life sciences company with R&D and production facilities in Cape Town and headquarters in Boulder, Colorado, is seeking a Process Development Associate Engineer to join their Process Development team. The company specializes in enzyme engineering and computational biology to develop products for genomics, molecular diagnostics, and personalized medicine.
In this role, you will apply process engineering expertise to design and transfer reagent filling and assembly processes for finished goods manufacturing. You will work collaboratively across R&D, Production, IT, and Quality Assurance teams at global sites to deliver high-quality, innovative products.
Key responsibilities include:
- Identifying critical process parameters (CPPs) and critical-to-quality attributes (CQAs) to ensure consistent product quality
- Developing or adapting processes to meet specifications through investigation, experimentation, and equipment evaluation
- Planning and executing project deliverables with proactive communication of status and outcomes
- Contributing to process, equipment, and computer systems validation, and material qualification
- Identifying, documenting, and mitigating process risks
- Designing robust experiments for process development and comprehensively documenting results
- Applying ISO 13485 standards and internal SOPs in daily work
- Supporting on-market products by investigating process-related issues through data analysis and experimentation
- Authoring work instructions, batch record templates, and production-facing documentation
- Preparing training materials and conducting operator training on new or revised procedures
You will support the transfer of new products from R&D to manufacturing by translating product requirements into process specifications and developing efficient, scalable processes. After product launch, you will provide ongoing support for process updates to maintain quality.
Required skills include systems-level thinking for designing robust, scalable manufacturing processes; demonstrated scientific excellence in technical work and communication; adaptability and ability to learn quickly; critical thinking and problem-solving; commitment to continuous improvement; strong interpersonal skills; excellent organizational skills and attention to detail; self-motivation; and excellent written and verbal communication.
Advantageous experience includes technical understanding of PCR, next-generation sequencing (NGS), protein biochemistry, mid-scale life science reagent manufacturing and scale-up, analytical measurement methods, statistical process design (DOE, SPC), statistical techniques (regression, ANOVA, t-tests), risk management frameworks (FMEA), and ISO 9001/13485 standards or quality management systems.
Requirements:
- BSc/BEng in Process or Chemical Engineering with 0–2+ years relevant experience in process engineering or biotechnology, OR
- MSc in molecular biology, enzymology, or related fields with 2+ years demonstrated industry experience in process development
- Must be South African or eligible to work in South Africa with necessary work permits or visas
- Applications must include a letter of motivation and resume/CV highlighting relevant qualifications and experience
