Process Development Associate, Fill

**Department**: Process Development

**Position Type**: Full-Time Employee

**Location**: Cape Town, South Africa (on-site)

**Experience**: Minimum BSc/BEng in Process/Chemical Engineering with 0 - 2+ years relevant experience in process engineering or biotechnology

**Company Summary**

**Position Summary**

We are seeking an R&D Associate, Fill & Finish to join our Process Development team in Cape Town, South Africa.

**Key Responsibilities**

The Process Development team supports the transfer of new products from R&D to manufacturing. This involves translating product requirements into process specifications and developing efficient, scalable processes to meet these needs. After product launch, the team provides ongoing support for process updates to maintain product quality.

Specific responsibilities include:

- Identifying critical process parameters (CPPs) that ensure critical-to-quality attributes (CQAs) are consistently achieved.
- Assisting in developing or adapting processes to meet CPPs by investigating new methods, equipment and controls, and confirming suitability through experimentation.
- Identifying opportunities for process streamlining, standardization, and alignment with industry best practices.
- Planning and executing assigned project deliverables and proactively communicating status and outcomes.
- Contributing to process, equipment, and computer systems validation, as well as material qualification, by establishing clear, testable specifications based on CPPs and CQAs, along with associated experimental planning.
- Identifying and documenting process risks, assessing potential impacts, and developing appropriate mitigations.
- Contributing to robust, rigorous experimental design for the development and testing of new processes and comprehensively document outcomes.
- Supporting on-market products by investigating process-related issues through data trending, analysis, or experimentation.
- Authoring and revising work instructions, batch record templates, and other production-facing documentation that are clear and concise to ensure reproducible results.
- Preparing training materials and conducting classroom and on-the-job training of operators on new or revised procedures.

**Required skills**
- Predisposition for systems-level thinking, as applied to designing and implementing robust, scalable processes for finished goods manufacturing.
- Demonstrated scientific excellence in technical work, written communication and presenting technical information to groups with various scientific backgrounds.
- Critical thinking and problem-solving skills.
- Commitment to a culture of excellence and advocacy for continuous improvement.
- Strong interpersonal skills and an excellent ability to drive results in multi-level, cross-functional teams.
- Excellent organizational skills and outstanding 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.).
- Mid-scale life science reagent and finished goods manufacturing and scale-up.
- Analytical measurement methods and assessing process capabilities, using statistical techniques such as Measurement Systems Analysis (MSA) or Gauge Repeatability & Reproducibility (Gauge R&R).
- Designing and monitoring processes using statistical methods such as Design of Experiments (DOE) and Statistical Process Control (SPC).
- General statistical techniques such as regression analysis and significance testing (e.g., Analysis of Variance (ANOVA), t-tests).
- Risk management and hazard analysis frameworks or tools, such as Failure Modes and Effects Analysis (FMEA).
- ISO 9001 and/or ISO 13485 standards or operating within a structured quality management system (QMS).

**Requirements**:

- BSc/BEng in Process/Chemical Engineering with 0 - 2+ years relevant experience in process engineering or biotechnology

OR
- MSc in molecular biology/enzymology or related fields with 2+ years demonstrated industry experience in process development.

**Application Requirements**
- Letter of motivation (upload where it says cover letter)
- Resume or _Curriculum vitae_, highlighting relevant qualifications and experience

If selected to participate in the interview process, the names and contact information of three professional references who are able to assess your suitability for the position in terms of the specified requirements will be requested.
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**_ SOUTH AFRICA - 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