1,758 Validation Engineer jobs in South Africa

Fine Chemicals requires the services of a Validation Engineer for our Engineering Department

Job specification: The position requires an individual with demonstrated interpersonal skills, leadership and management ability, assertiveness, and pragmatism. Technically, the position requires a high level of knowledge and skills in the following:

• Demonstrated understanding of chemical process equipment operation/installation/design and maintenance.


• Basic understanding or process control systems.


• Understanding technical specifications and drawings.


• Commissioning and qualification of equipment and systems in a GMP environment.


• OHS Act + Safe working practices and general industrial health and safety.


• Problem Solving, Leadership and General Supervisory Skills.


• Knowledge of cGMPs as applied in an FDA-controlled environment, preferred.

Experience: Experience in validation of equipment and systems within a GMP environment would be advantageous. Min 5 yrs experience in design, installation, commissioning / qualification, operation or maintenance of chemical process plant and equipment.

Personal attributes and qualifications:

• Min National Diploma in Chemical or Mechanical Engineering or BSC Chemistry (or similar)


• High standard of computer literacy and technical report writing.


• An assertive individual with good communication, organisational and interpersonal skills who thrives under pressure.


• Systematic and Analytical by nature.


• Must be of sound health, have own transport.

Principle objectives of the position:  

• Responsible for appropriate application of validation and qualification policies and procedures to new and existing equipment, systems, facilities and utilities used in the manufacturing of intermediate and finished active pharmaceutical ingredients (API).


• Ensure validation compliance through coordinating the practical aspects of equipment validation and qualification as it pertains to the manufacturing enviroment, within the required timeframes.


• Maintenance (and generation of) of all validation related documentation and databases including, site master validation plan, various project master validation plans, Engineering Change Controls, ISO 14644 Compliance documents.


• Generation and maintenance of re-validation or re-qualification plans for all process equipment /systems as per the Site Master Validation Plan and associated Modular verification Procedure.


• Assisting with process and equipment related risk assessments.


• Supervising of Validation technicians and Interns as required.

Suitably qualified applicants are invited to submit their CV’s online on or before the specified date. Preference will be given to applicants from designated groups in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate. If you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.

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.

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.

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.

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.

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.

***

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.

About Sutherland

Artificial Intelligence. Automation. Cloud engineering. Advanced analytics. For business leaders, these are key factors of success. For us, they’re our core expertise.

We work with iconic brands worldwide. We bring them a unique value proposition through market-leading technology and business process excellence.

We’ve created over 200 unique inventions under several patents across AI and other critical technologies. Leveraging our advanced products and platforms, we drive digital transformation, optimize critical business operations, reinvent experiences, and pioneer new solutions, all provided through a seamless “as a service” model.

For each company, we provide new keys for their businesses, the people they work with, and the customers they serve. We tailor proven and rapid formulas, to fit their unique DNA. We bring together human expertise and artificial intelligence to develop digital chemistry. This unlocks new possibilities, transformative outcomes and enduring relationships.

Job Description

Monitoring & Evaluation: Consistently monitor inbound and outbound customer service interactions across various channels (calls, email, chat). Quality Audits: Conduct regular audits and assessments of agent performance against a predefined checklist of quality parameters. Feedback & Coaching: Provide detailed, constructive feedback and coaching to agents to improve their performance and address any quality issues. Data Analysis: Analyze key performance indicators (KPIs) such as CSAT and FRT to identify trends and pinpoint areas for improvement in service quality. Process Improvement: Develop and implement quality assurance guidelines, procedures, and strategies to enhance overall service quality and operational efficiency. Reporting: Prepare and present clear, data-driven quality reports to management and stakeholders. Collaboration: Work with training teams to enhance training programs and onboard new employees to ensure consistent quality standards. Compliance: Ensure that all processes and interactions comply with company policies and regulations.

Qualifications

• Essential: Grade 12
• Preferred: Tertiary qualification in management or relevant proven contact center experience

Experience, Knowledge, Skills and Attributes Required:

• A proven track record of delivering against client, customer and business outcomes
• 2 years’ experience working within BPO - Customer Service
• 3 years of Quality Assurance experience
• Be able to work in MS Office
• Be able to work in a fast-paced environment
• Have strong analytical skills
• Have strong verbal and written communication skills

All your information will be kept confidential according to EEO guidelines.

• Mid-Senior level

• Full-time

• Administrative
• Telecommunications

Company Description

About Sutherland

Artificial Intelligence. Automation. Cloud engineering. Advanced analytics. For business leaders, these are key factors of success. For us, they’re our core expertise.

We work with iconic brands worldwide. We bring them a unique value proposition through market-leading technology and business process excellence.

We’ve created over 200 unique inventions under several patents across AI and other critical technologies. Leveraging our advanced products and platforms, we drive digital transformation, optimize critical business operations, reinvent experiences, and pioneer new solutions, all provided through a seamless “as a service” model.

For each company, we provide new keys for their businesses, the people they work with, and the customers they serve. We tailor proven and rapid formulas, to fit their unique DNA. We bring together human expertise and artificial intelligence to develop digital chemistry. This unlocks new possibilities, transformative outcomes and enduring relationships.

Sutherland
Unlocking digital performance. Delivering measurable results.

Monitoring & Evaluation: Consistently monitor inbound and outbound customer service interactions across various channels (calls, email, chat).

Quality Audits: Conduct regular audits and assessments of agent performance against a predefined checklist of quality parameters.

Feedback & Coaching: Provide detailed, constructive feedback and coaching to agents to improve their performance and address any quality issues.

Data Analysis: Analyze key performance indicators (KPIs) such as CSAT and FRT to identify trends and pinpoint areas for improvement in service quality.

Process Improvement: Develop and implement quality assurance guidelines, procedures, and strategies to enhance overall service quality and operational efficiency.

Reporting: Prepare and present clear, data-driven quality reports to management and stakeholders.

Collaboration: Work with training teams to enhance training programs and onboard new employees to ensure consistent quality standards.

Compliance: Ensure that all processes and interactions comply with company policies and regulations.

Qualifications Required:

• Essential: Grade 12
• Preferred: Tertiary qualification in management or relevant proven contact center experience

Experience, Knowledge, Skills and Attributes Required:

• A proven track record of delivering against client, customer and business outcomes
• 2 years’ experience working within BPO - Customer Service
• 3 years of Quality Assurance experience
• Be able to work in MS Office
• Be able to work in a fast-paced environment
• Have strong analytical skills
• Have strong verbal and written communication skills

All your information will be kept confidential according to EEO guidelines.

Overview

Sutherland
Unlocking digital performance. Delivering measurable results.

Monitoring & Evaluation: Consistently monitor inbound and outbound customer service interactions across various channels (calls, email, chat).

• Monitoring & Evaluation: Consistently monitor inbound and outbound customer service interactions across various channels (calls, email, chat).
• Quality Audits: Conduct regular audits and assessments of agent performance against a predefined checklist of quality parameters.
• Feedback & Coaching: Provide detailed, constructive feedback and coaching to agents to improve their performance and address any quality issues.
• Data Analysis: Analyze key performance indicators (KPIs) such as CSAT and FRT to identify trends and pinpoint areas for improvement in service quality.
• Process Improvement: Develop and implement quality assurance guidelines, procedures, and strategies to enhance overall service quality and operational efficiency.
• Reporting: Prepare and present clear, data-driven quality reports to management and stakeholders.
• Collaboration: Work with training teams to enhance training programs and onboard new employees to ensure consistent quality standards.
• Compliance: Ensure that all processes and interactions comply with company policies and regulations.

• Qualifications Required:

• Essential: Grade 12
• Preferred: Tertiary qualification in management or relevant proven contact center experience

• A proven track record of delivering against client, customer and business outcomes
• 2 years’ experience working within BPO - Customer Service
• 3 years of Quality Assurance experience
• Be able to work in MS Office
• Be able to work in a fast-paced environment
• Have strong analytical skills
• Have strong verbal and written communication skills

All your information will be kept confidential according to EEO guidelines.