189 Process Validation jobs in South Africa

Join to apply for the Validation Engineer role at Aspen Pharma Group . 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 role demands: Understanding of chemical process equipment operation, installation, design, and maintenance. Basic knowledge of process control systems. Ability to interpret technical specifications and drawings. Experience with commissioning and qualification of equipment in a GMP environment. Knowledge of OHS Act and safe working practices. Problem-solving, leadership, and supervisory skills. Knowledge of c GMPs in an FDA-controlled environment is preferred. Experience: Minimum 5 years in validation of equipment and systems within a GMP environment, with experience in design, installation, commissioning/qualification, operation, or maintenance of chemical process plant and equipment. Qualifications and Attributes: National Diploma in Chemical or Mechanical Engineering or BSc Chemistry (or similar). High computer literacy and technical report writing skills. Assertive with good communication, organizational, and interpersonal skills; thrives under pressure. Systematic and analytical by nature. Must be in good health and have own transport. Principle Objectives: Apply validation and qualification policies to new and existing equipment, systems, facilities, and utilities used in API manufacturing. Ensure validation compliance by coordinating validation activities within required timeframes. Maintain validation documentation and databases, including validation plans and compliance documents. Develop and maintain re-validation plans as per the Site Master Validation Plan. Assist with risk assessments related to processes and equipment. Supervise validation technicians and interns as required. Suitable candidates are encouraged to submit their CVs online before the deadline. Preference will be given to applicants from designated groups, in accordance with employment equity laws. If you do not hear from HR within 30 days, consider your application unsuccessful. #J-18808-Ljbffr

Join to apply for the Validation Engineer role at Aspen Pharma Group . 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 role demands: Understanding of chemical process equipment operation, installation, design, and maintenance. Basic knowledge of process control systems. Ability to interpret technical specifications and drawings. Experience with commissioning and qualification of equipment in a GMP environment. Knowledge of OHS Act and safe working practices. Problem-solving, leadership, and supervisory skills. Knowledge of c GMPs in an FDA-controlled environment is preferred. Experience: Minimum 5 years in validation of equipment and systems within a GMP environment, with experience in design, installation, commissioning/qualification, operation, or maintenance of chemical process plant and equipment. Qualifications and Attributes: National Diploma in Chemical or Mechanical Engineering or BSc Chemistry (or similar). High computer literacy and technical report writing skills. Assertive with good communication, organizational, and interpersonal skills; thrives under pressure. Systematic and analytical by nature. Must be in good health and have own transport. Principle Objectives: Apply validation and qualification policies to new and existing equipment, systems, facilities, and utilities used in API manufacturing. Ensure validation compliance by coordinating validation activities within required timeframes. Maintain validation documentation and databases, including validation plans and compliance documents. Develop and maintain re-validation plans as per the Site Master Validation Plan. Assist with risk assessments related to processes and equipment. Supervise validation technicians and interns as required. Suitable candidates are encouraged to submit their CVs online before the deadline. Preference will be given to applicants from designated groups, in accordance with employment equity laws. If you do not hear from HR within 30 days, consider your application unsuccessful. #J-18808-Ljbffr

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.

Job Responsibilities

• Interpret applicable industry specifications and characteristics to realize suitable verification strategies and methods required to ensure quality of airborne satellite data equipment.
• Definition and scheduling of V&V activities, control points and outputs to align with project milestones.
• Development and establishment of V&V environments required for the execution of Test Cases and Test Procedures.
• Execution of test campaigns with alignment to project milestones.
• Development and execution of Test Cases and Procedures.
• Primary stakeholder of software defects tracking procedure.

Results reporting to stakeholders.

Job Requirements

• BEng (Electronic/Computer) / BSc (Hons) Computer science/ BSc Engineering Computer science.
• Experience with:

• Translation of System and Software requirements into V&V activities, control points and outputs (starting at Planning phase and applied throughout product development life cycle phases - including the product maintenance phase).
• Establishment of V&V environments/configurations/setups.
• The management, development, execution and automation of test cases and test procedures.
• The planning and scheduling of V&V activities in line with product delivery milestones.
• Software V&V processes and process flows including defects management.
• Data packet analysis and analysis tools (eg Wireshark, tcpdump etc).
• Circuit Switched services (basic call setup/teardown).
• Hardware interfaces such as Ethernet, PoE, ARINC-429, RS422/232, POTS 2-wire, ISDN S/T interface will be advantageous.
• Protocols such as BGAN, HTTP, SIP, SLIP, PPP, PPPoE, L2TP, PoE, RTP, POTS, IPsec, UDP, TCP, 3GPP AT-commands.
• Linux-based tool chains potentially used for automation, user interfaces, and clients such as pppd, tc, iptables, Linux Telnet client, Net-SNMP, tc, sipp, nc, ab, git, expect.

• Knowledge of the Inmarsat BGAN network or 3GPP (strong recommendation).
• Hands-on experience with DO-178 level D Integral processes and associated objectives.
• A firm working understanding of:

• Packet networking, including access types (L2/L3).
• IP routing, IP telephony, and the IP security protocol suites.

• Strong technical writing skills – V&V documentation, product documentation (such as test specifications, application notes and user manuals).
• Be goal oriented, good verbal communication skills and self-driven.

Previous engineering experience in avionics or medical product development/verification environments will be advantageous.

Affirmative Action and/or EE candidates will be given first preference as per our employment equity strategies.

#J-18808-Ljbffr

Job Responsibilities Interpret applicable industry specifications and characteristics to realize suitable verification strategies and methods required to ensure quality of airborne satellite data equipment. Definition and scheduling of V&V activities, control points and outputs to align with project milestones. Development and establishment of V&V environments required for the execution of Test Cases and Test Procedures. Execution of test campaigns with alignment to project milestones. Development and execution of Test Cases and Procedures. Primary stakeholder of software defects tracking procedure. Results reporting to stakeholders. Job Requirements BEng (Electronic/Computer) / BSc (Hons) Computer science/ BSc Engineering Computer science. Experience with: Translation of System and Software requirements into V&V activities, control points and outputs (starting at Planning phase and applied throughout product development life cycle phases - including the product maintenance phase). Establishment of V&V environments/configurations/setups. The management, development, execution and automation of test cases and test procedures. The planning and scheduling of V&V activities in line with product delivery milestones. Software V&V processes and process flows including defects management. Data packet analysis and analysis tools (eg Wireshark, tcpdump etc). Circuit Switched services (basic call setup/teardown). Hardware interfaces such as Ethernet, Po E, ARINC-429, RS422/232, POTS 2-wire, ISDN S/T interface will be advantageous. Protocols such as BGAN, HTTP, SIP, SLIP, PPP, PPPo E, L2 TP, Po E, RTP, POTS, IPsec, UDP, TCP, 3 GPP AT-commands. Linux-based tool chains potentially used for automation, user interfaces, and clients such as pppd, tc, iptables, Linux Telnet client, Net-SNMP, tc, sipp, nc, ab, git, expect. Knowledge of the Inmarsat BGAN network or 3 GPP (strong recommendation). Hands-on experience with DO-178 level D Integral processes and associated objectives. A firm working understanding of: Packet networking, including access types (L2/L3). IP routing, IP telephony, and the IP security protocol suites. Strong technical writing skills – V&V documentation, product documentation (such as test specifications, application notes and user manuals). Be goal oriented, good verbal communication skills and self-driven. Previous engineering experience in avionics or medical product development/verification environments will be advantageous. Affirmative Action and/or EE candidates will be given first preference as per our employment equity strategies. #J-18808-Ljbffr

Job Responsibilities Interpret applicable industry specifications and characteristics to realize suitable verification strategies and methods required to ensure quality of airborne satellite data equipment. Definition and scheduling of V&V activities, control points and outputs to align with project milestones. Development and establishment of V&V environments required for the execution of Test Cases and Test Procedures. Execution of test campaigns with alignment to project milestones. Development and execution of Test Cases and Procedures. Primary stakeholder of software defects tracking procedure. Results reporting to stakeholders. Job Requirements BEng (Electronic/Computer) / BSc (Hons) Computer science/ BSc Engineering Computer science. Experience with: Translation of System and Software requirements into V&V activities, control points and outputs (starting at Planning phase and applied throughout product development life cycle phases - including the product maintenance phase). Establishment of V&V environments/configurations/setups. The management, development, execution and automation of test cases and test procedures. The planning and scheduling of V&V activities in line with product delivery milestones. Software V&V processes and process flows including defects management. Data packet analysis and analysis tools (eg Wireshark, tcpdump etc). Circuit Switched services (basic call setup/teardown). Hardware interfaces such as Ethernet, Po E, ARINC-429, RS422/232, POTS 2-wire, ISDN S/T interface will be advantageous. Protocols such as BGAN, HTTP, SIP, SLIP, PPP, PPPo E, L2 TP, Po E, RTP, POTS, IPsec, UDP, TCP, 3 GPP AT-commands. Linux-based tool chains potentially used for automation, user interfaces, and clients such as pppd, tc, iptables, Linux Telnet client, Net-SNMP, tc, sipp, nc, ab, git, expect. Knowledge of the Inmarsat BGAN network or 3 GPP (strong recommendation). Hands-on experience with DO-178 level D Integral processes and associated objectives. A firm working understanding of: Packet networking, including access types (L2/L3). IP routing, IP telephony, and the IP security protocol suites. Strong technical writing skills – V&V documentation, product documentation (such as test specifications, application notes and user manuals). Be goal oriented, good verbal communication skills and self-driven. Previous engineering experience in avionics or medical product development/verification environments will be advantageous. Affirmative Action and/or EE candidates will be given first preference as per our employment equity strategies. #J-18808-Ljbffr

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.

***

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.

#J-18808-Ljbffr

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 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. 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. Desired Experience & Qualification 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 c GMP 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. Interested? Application Procedure To apply for the position, please submit the following in PDF format on Indeed (Add Link here): 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. *** 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. #J-18808-Ljbffr

Our esteemed client is looking for a Quality Engineer (Electronic Engineering) to join their team in Westmead, Durban . Youll be responsible for testing, troubleshooting, and ensuring the quality of our collision avoidance systems, including visual inspections, hardware and firmware testing, and configuration to client specs.

Applicants should have a BEng/BTech in Engineering , 12 years relevant experience, strong attention to detail, and proficiency with test equipment. A valid drivers license and willingness to travel to our Benoni head office are required. Apply now to be part of a team driving innovation in safety technology.

Education:

• BEng Tech in Electrical Engineering, Electronics, Mechatronics, or a related field .

Job Experience & Skills Required:

• Conduct visual inspections on all products according to established quality standards.
• Perform hardware functionality tests to ensure optimal performance.
• Test various firmware applications.
• Interpret and implement configurations to meet client specifications.
• Provide remote technical support to Engineers and Technicians on site.
• Compile accurate documentation and detailed reports.
• Proficient with test equipment (power supplies, multimeters, and oscilloscopes).
• Experience in designing and using test jigs.
• Basic understanding of embedded systems.

Apply now!