Process Development Scientist - Validation Lead

Watchmaker Genomics; Cape Town; On-site; ZAR 500,000 - 900,000; Full time

Job summary

Watchmaker Genomics, a leading life science company, is seeking a full-time Validation Lead based in Cape Town. The successful candidate will coordinate validation activities across global sites, requiring a strong background in validation protocols and experience in biotech. This collaborative role demands excellent communication and organizational skills.

Qualifications

• 3 years industry experience in biotech or related fields.
• Certification as a validation engineer preferred (e.g., CVP, CQVE).
• Experience in ISO, cGMP industries.

Responsibilities

• Manage the entire validation lifecycle from planning to maintenance.
• Develop and implement the validation strategy and program.
• Oversee validation of infrastructure and processes.

Skills

Statistical methods

Scientific communication

Presentation skills

Multitasking

Organizational skills

Education

MSc in molecular biology

BEng Hons in Engineering

Job description

Watchmaker Genomics - Validation Lead Position

Watchmaker Genomics is a global life science company with an R&D and Production facility in Cape Town, South Africa, and head offices in Boulder, Colorado.

Our team is passionate about innovation and values collaboration, creativity, and scientific rigor.

We believe that the intersection of biology, engineering, and computer science presents exciting opportunities for developing novel technologies that promote research and improve human health.

Watchmaker Genomics specializes in the design, development, and production of DNA- and RNA-modifying enzymes that enable high-growth applications in genomics, molecular diagnostics, and personalized medicine. We are inviting applications for a full-time Validation Lead position based in Cape Town, South Africa.

This position reports to the Process Development Lead and will be responsible for coordinating validation activities across our global sites.

This highly collaborative role involves working closely with departments such as R&D, Production, IT, and Quality Assurance.

The successful candidate will thrive in a dynamic, fast-paced environment and contribute to our company culture and success.

Responsibilities

• Manage the entire validation lifecycle from planning through review and maintenance of validated status.
• Develop and implement the validation strategy and program.
• Coordinate validation activities with internal teams and external service providers.
• Oversee validation of infrastructure, utilities, equipment, software, processes, and test methods.
• Author and maintain validation procedures, protocols, and reports.
• Review qualification protocols and reports from third-party providers.
• Provide technical expertise and training on validation activities, including risk assessments and user requirements.

Desired Skills & Qualifications

• Experience in planning and executing validation protocols (process, computer systems, test methods, equipment qualification).
• Ability to design and monitor systems using statistical methods (DOE, SPC, Regression, ANOVA, Gage R&R).
• Experience in ISO, cGMP industries related to process development, quality assurance, or operations.
• Broad technical knowledge of life science reagents, genomics, NGS, PCR, or recombinant protein production is highly desirable.
• Strong scientific, communication, and presentation skills.
• Ability to multitask, work under pressure, and work independently.
• Excellent organizational and interpersonal skills.

Education & Experience

• MSc in molecular biology, biochemistry, or BEng Hons in Engineering or related discipline.
• At least 3 years of industry experience in biotech or related fields.
• Certification as a validation engineer (e.g., CVP, CQVE) is preferred.

Application Procedure

Submit in PDF format via Indeed: a letter of motivation and your CV highlighting relevant experience. Applications without a motivation letter will not be considered.

Local candidates preferred. References from three assessors may be requested during the interview process.

Equal Opportunity Statement

We are an equal opportunity employer committed to diversity. All qualified applicants will receive consideration regardless of race, color, religion, gender, sexual orientation, or other protected characteristics. All employment is contingent upon eligibility to work in South Africa and may include pre-employment checks.