Development Lead Cape Town

Watchmaker Genomics; Cape Town; On-site; ZAR 40 000 - 80 000; Full time

Job summary

An innovative life science company is seeking a Validation Lead to oversee validation activities in a dynamic environment. This role involves managing the validation lifecycle, coordinating with various departments, and ensuring high-quality product delivery. The ideal candidate will have a strong background in validation protocols and statistical methods, along with excellent communication and organizational skills. Join a passionate team dedicated to advancing research and improving human health through cutting-edge technologies in genomics and molecular diagnostics.

Qualifications

• Experience in planning and executing validation protocols.
• Ability to design systems using statistical methods like DOE and SPC.
• Broad technical knowledge in life sciences and genomics.

Responsibilities

• Manage validation activities from planning to review.
• Develop strategies and coordinate validation activities.
• Author and maintain validation documents and reports.

Skills

Validation Protocols

Statistical Methods

ISO/cGMP Compliance

Life Science Knowledge

Communication Skills

Organizational Skills

Education

MSc in Molecular Biology

BEng Hons in Engineering

Tools

Statistical Process Control (SPC)

Design of Experiments (DOE)

Job description

Watchmaker Genomics - Validation Lead

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 coordinate validation activities across our global sites. It involves close collaboration with R&D, Production, IT, and Quality Assurance teams.

The successful candidate will thrive in a dynamic, fast-paced environment and contribute to our company culture and success. The role offers an opportunity to drive validation activities ensuring high-quality product delivery.

Duties & Responsibilities

1. Validation lifecycle management: Managing validation activities from planning to review and maintenance.
2. Implement and manage validation programs: Develop strategies and coordinate validation activities with relevant departments and external providers.
3. Oversee validation of: Infrastructure, utilities, cleaning, equipment, software, processes, and test methods.
4. Author and maintain validation documents: Protocols, plans, reports, and review third-party validation reports.
5. Provide technical expertise and training: System risk assessments, user requirements, project plans, and validation activities.

Desired Experience & Qualifications

• Experience in planning and executing validation protocols, including process, computer systems, test methods, and equipment qualification.
• Ability to design and monitor systems using statistical methods like DOE, SPC, Regression, ANOVA, and Gage R&R.
• ISO and/or cGMP industry experience in Process Development, Quality Assurance, or related fields.
• 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 in biotech or related industry, with broad functional experience.
• Validation engineer certification (e.g., CVP or CQVE) preferred.

Application Procedure

To apply, submit a PDF with a Letter of Motivation and CV via Indeed. Applications without a motivation letter will not be considered. Local candidates preferred. References may be requested during the interview process.

We are an equal opportunity employer committed to diversity and inclusion. All qualified applicants will receive consideration without regard to protected characteristics. Pre-employment checks may include background, driving, and drug screening, complying with applicable laws.