Process Development Scientist, Systems

**Department**: Process Development

**Position Type**: Full-Time Employee

**Location**: Cape Town, South Africa (on-site)

**Experience**: BSc/BEng in Process/Chemical Engineering with 5-8+ years relevant experience in process engineering or biotechnology OR PhD in molecular biology/enzymology or related fields with 0-5+ years demonstrated industry experience in process development

**Company Summary**

We are seeking an R&D Scientist to join our Process Development team in Cape Town, South Africa.

**Key Responsibilities**
- Collaborate globally with R&D, QA, Operations, Product Management and Commercial teams to improve the quality, efficiency, and scalability of high-level processes
- Independently learn, comprehend, and characterize operational processes
- Integrate data-driven decision making across various departments through implementation of process monitoring, trending, and evaluation
- Strategically evaluate processes for effectiveness, devise improvements and implement change
- Author, revise, and publish process maps, work instructions, batch record templates, risk analyses (e.g. FMEA) and related documentation
- Create training content, train process users, and build scalable training programs
- Clearly communicate process designs, analyses, and changes to both technical and non-technical audiences
- Lead projects and drive change management strategy for improving and scaling various process systems, such as:
- New Product Development (NPD)
- Post-market product care
- Manufacturing and Quality Control workflows
- Process development workflows and templates
- Participate, provide guidance, and lead in non-conformance investigations, root cause analyses, risk assessments, and corrective and preventive action (CAPA) plans
- Support a variety of projects aimed at launching products, completing key initiatives, or validating process systems
- Ensure compliance with all relevant regulatory requirements, including ISO 13485 guidelines
- Other duties as assigned

**Skills and Requirements**

Required skills
- Advanced computer proficiency and experience with business systems including process mapping software and Microsoft and/or Google Suite software
- Experience project managing and leading technical projects with cross-functional teams
- Familiarity with various business systems/softwares such as Inventory Management and Enterprise Resource Management (ERP), Quality Management Systems (QMS), and Manufacturing Execution Systems (MES)
- Experience designing and improving processes
- Experience operating within a QMS and driving nonconformance investigations, root cause analysis, corrective and preventive action (CAPA), change control, process validation and design verification, and risk management tools like failure mode and effect analysis (FMEA)
- Critical thinking and problem-solving skills
- Excellent organizational skills and attention to detail
- The ability to multitask, be able to work at a high standard, perform consistently under pressure along with pre-determined deadlines, and work without supervision
- Strong interpersonal skills and an ability to work as an effective member of a team

Advantageous skills
- Technical knowledge and practical expertise with enzymology and/or molecular biology techniques such as, but not limited to, protein purification, PCR, and next generation sequencing (NGS)
- Certification or training in project management and experience with relevant software, e.g. Smartsheets, Jira, Monday, MS Projects
- Proven knowledge of ISO 13485 standards and how to operate within a structured quality management system (QMS)
- Six sigma, 5S, ASQ, Kaizen or other training/certifications relevant to process improvement
- Experience in statistical analysis techniques such as Design of Experiments (DOE), Analysis of Variation (ANOVA), measurements of central tendency, etc.

**Education and Experience**
- BSc/BEng in Process/Chemical Engineering with 5-8+ years relevant experience in process engineering or biotechnology

OR
- PhD in molecular biology/enzymology or related fields with 0-5+ years demonstrated industry experience in process development

**Application Requirements**
- Letter of motivation (upload where it says cover letter)
- Resume or _Curriculum vitae_, highlighting relevant qualifications and experience

If selected to participate in the interview process, the names and contact information of three professional references who are able to assess your suitability for the position in terms of the specified requirements will be requested. We will also request a current payslip.
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**_ NO RECRUITMENT AGENCIES PLEASE_**
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**_ SOUTH AFRICA - WE ARE AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER_**
- Watchmaker Genomics is committed to being an equal opportunity employer and creating a culturally diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, s