Process Development Scientist

3 months ago

Cape Town, South Africa Watchmaker Genomics Full time

**Responsibilities**
- Validation life cycle management: Managing the entire life cycle 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

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 risk assessments and required level of validation
- Identification of user requirements
- Project plans, protocols and reports
- Provide expertise related to relevant validation activities

**Skills and Requirements**

The following skills and experience are requirements for the position:

- Experience in planning and executing validation protocols - including process validation, computer systems validation, test method validation and/or equipment qualification
- 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)
- ISO 13485, ISO 9001, and/or cGMP industry experience in Process Development, Quality Assurance, Quality Systems, Operations, or other related field
- Broad technical knowledge of life science reagents, genomics, next-generation sequencing (NGS), PCR and/or recombinant protein production are all highly desirable
- Demonstrated scientific excellence in technical work, written communication and presenting technical information to groups with various scientific backgrounds
- The ability to multitask, perform consistently under pressure and work without supervision
- Strong interpersonal skills and an excellent ability to drive results in multi-level, cross-functional teams
- Excellent organisational skills and outstanding attention to detail
- Good communication and personal task management skills and a high level of self-motivation
- Ability to determine project timelines and meet deadlines
- Excellent written and verbal communication skills

**Education and Experience**
- An MSc in molecular biology, biochemistry or BEng Hons in Engineering or a related discipline is required
- 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
- Certification or qualification as a validation engineer, such as Certified Validation Professional (CVP) or Certified Quality Validation Engineer (CQVE) is preferred

**Application Procedure**
- Letter of motivation
- _Curriculum vitae_, highlighting relevant qualifications and experience

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.
- **_
- **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._

**Job Types**: Full-time, Permanent

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