We are seeking a full-time Validation Lead to join our Process Development Team in Cape Town, South Africa.

As part of the Process Development team, you will coordinate all 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, Operations, IT, and Quality Assurance.

Responsibilities

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

Required skills

• Experience in planning and executing validation protocols - including process validation, computer systems validation, test method validation, and/or equipment qualification
• ISO 13485, ISO 9001, and/or cGMP industry experience in Process Development, Quality Assurance, Quality Systems, Operations, or other related field
• Demonstrated experience managing complex, multi-functional projects
• Adaptability, curiosity, and the ability to grasp and apply new concepts quickly
• Critical thinking and problem-solving skills
• Commitment to a culture of excellence and advocacy for continuous improvement
• Strong interpersonal skills with the ability to effectively communicate across multi-level, cross-functional teams
• Excellent organizational skills and attention to detail
• Strong personal task management skills and a high level of self-motivation
• Excellent written and verbal communication skills

Advantageous skills

• Technical understanding of and/or experience with:
• PCR, next-generation sequencing (NGS) techniques, and basic protein biochemistry (e.g., physical properties, experimental methods, enzyme kinetics, etc.)
• Assessing analytical measurement methods and process capabilities, using statistical techniques such as Measurement Systems Analysis (MSA) or Gauge Repeatability & Reproducibility (Gauge R&R)
• Risk management and hazard analysis frameworks or tools, such as Failure Modes and Effects Analysis (FMEA)
• Project Management Professional (PMP) certification
• High degree of computer literacy and ability to consolidate information across different software platforms

Please note: The above responsibilities are not exhaustive and other similar duties may be required from time to time.

Education and Experience

• M Eng in Process Engineering or an MSc in molecular biology, biochemistry or a related discipline is required
• A minimum of 5 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
• Certification or qualification as a validation engineer, such as Certified Validation Professional (CVP) or Certified Quality Validation Engineer (CQVE) is preferred

Application Procedure

To apply for the position, please submit the following in PDF format

• Letter of motivation
• 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.

To ensure your application is considered, please submit it by Friday, 25 April 2025. Please note that this position may close earlier if we receive a high volume of applications. We encourage you to apply as soon as possible.

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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.