Process Development Scientist - Validation Lead

Watchmaker Genomics; Cape Town; On-site; ZAR 900,000 - 1,300,000; Full time

Job summary

Watchmaker Genomics is seeking a Validation Lead to coordinate validation activities across global sites from its Cape Town base. You will manage the full validation lifecycle, develop strategies, and work with R&D, Production, IT and QA to ensure validated status.

The role requires MSc in molecular biology/biochemistry or engineering with 3+ years in biotech, plus experience with process and computer systems validation and DOE/SPC/Gage R&R.

Qualifications

• Experience in planning and executing validation protocols including process validation, computer systems validation, test method validation, and/or equipment qualification.
• Design and monitor systems using DOE, SPC, regression analysis, ANOVA, and Gage R&R.
• ISO 13485, ISO 9001 and/or cGMP experience in Process Development, QA, QMS, or Operations.
• Broad life science knowledge including reagents, genomics, NGS, PCR or recombinant protein production desirable.
• Strong written communication and ability to present to diverse scientific audiences.
• Ability to multitask, work under pressure and drive results in cross-functional teams.

Responsibilities

• Manage the entire lifecycle of validation activities from planning to post-execution review.
• Develop and implement the validation strategy and coordinate activities with sites and providers.
• Oversee validation of infrastructure, utilities, cleaning, equipment, software systems, processes, and test methods.
• Author and maintain validation documents, protocols, and reports; review third-party qualification reports.
• Provide validation expertise and training; perform risk assessment and identify user requirements.

Skills

Validation protocols

Design of Experiments

Statistical methods

Gage R&R

Cross-functional teamwork

Strong communication

Education

MSc in molecular biology or biochemistry

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 to be based in Cape Town, South Africa. This position reports to the Process Development Lead and will be responsible for the coordination of validation activities across our global sites. This is a highly collaborative position that involves working closely with members of other departments such as R&D, Production, IT, and Quality Assurance. The successful candidate will thrive in a dynamic, fast-paced working environment and contribute directly to our company culture and success.

Duties & Responsibilities

Responsibilities

1. Validation lifecycle management: Managing the entire lifecycle of validation activities from initial planning through post-execution review and maintenance of validated status.
2. Implement and manage execution of the company validation program:
1. Develop and implement the validation strategy.
2. Coordinate validation activities with relevant areas and external service providers.
3. Oversee validation of:
1. Infrastructure and Utilities
2. Cleaning
3. Equipment
4. Software & Computer Systems (in collaboration with IT)
5. Processes, including Shipping
6. Test methods
3. Author and maintain validation procedures & documents:
1. Author and approve validation & project plans, protocols, and reports.
2. Review qualification protocols and reports of third-party service providers.
4. Provide technical expertise and training for validation activities:
1. System risk assessments and required level of validation.
2. Identification of user requirements.
3. Project plans, protocols, and reports.
4. Provide expertise related to relevant validation activities.

Desired Experience & Qualification

The following skills and experience are requirements for the position:

1. Experience in planning and executing validation protocols - including process validation, computer systems validation, test method validation, and/or equipment qualification.
2. Demonstrated ability to design and monitor systems using statistical methods such as Design of Experiments (DOE), Statistical Process Control (SPC), Regression Analysis, Analysis of Variance (ANOVA), and Gage Repeatability & Reproducibility (Gage R&R).
3. ISO 13485, ISO 9001, and/or cGMP industry experience in Process Development, Quality Assurance, Quality Systems, Operations, or other related field.
4. Broad technical knowledge of life science reagents, genomics, next-generation sequencing (NGS), PCR, and/or recombinant protein production are all highly desirable.
5. Demonstrated scientific excellence in technical work, written communication, and presenting technical information to groups with various scientific backgrounds.
6. The ability to multitask, perform consistently under pressure, and work without supervision.
7. Strong interpersonal skills and an excellent ability to drive results in multi-level, cross-functional teams.
8. Excellent organisational skills and outstanding attention to detail.
9. Good communication and personal task management skills and a high level of self-motivation.
10. Ability to determine project timelines and meet deadlines.
11. Excellent written and verbal communication skills.

Education and Experience

1. An MSc in molecular biology, biochemistry or BEng Hons in Engineering or a related discipline is required.
2. A minimum of 3 years in biotech or related industry is desirable, including positions with broad functional scope across research and development, technical transfers, manufacturing, quality control, and quality assurance.
3. Certification or qualification as a validation engineer, such as Certified Validation Professional (CVP) or Certified Quality Validation Engineer (CQVE) is preferred.

Interested?

Application Procedure

To apply for the position, please submit the following in PDF format on Indeed (Add Link here):

1. Letter of motivation
2. Curriculum vitae, highlighting relevant qualifications and experience

Applications without a Letter of Motivation will not be considered. Local candidates preferred.

If selected to participate in the interview process, the names and contact information of 3 references who are able to assess your suitability for the position in terms of the specified requirements will be requested.

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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, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics as protected by applicable law.

All applicants will be asked if currently eligible to work in South Africa; and if now or in the future will require visa sponsorship to continue working in South Africa.

This position may be subject to pre-employment checks, including driving history check, drug screening, and a background check for any convictions directly related to its duties and responsibilities. All pre-employment checks will comply with all applicable laws.