Senior Process Engineer - Pharmaceutical Manufacturing

Placements24; Johannesburg; Presencial; ZAR 1 200 000 - 2 000 000; Tempo integral

Resumo da oferta

Placements24 is seeking an experienced Senior Process Engineer for our client in Klerksdorp, North West. You will optimize, validate, and scale pharmaceutical manufacturing processes while ensuring GMP compliance and regulatory standards.

Strong troubleshooting and analytical skills are essential for driving ongoing improvements. The role requires a chemical or mechanical engineering background with 7+ years in pharma process engineering, including sterile manufacturing and API production.

Qualificações

• Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, or a related field.
• A minimum of 7 years of experience in process engineering within the pharmaceutical or related highly regulated industry.
• Proven experience in process development, optimization, and validation of pharmaceutical manufacturing processes (e.g., sterile manufacturing, solid dosage forms, API production).
• In-depth knowledge of GMP, FDA, and other relevant regulatory guidelines.
• Strong understanding of chemical/physical principles relevant to pharmaceutical manufacturing.
• Excellent analytical, problem-solving, and troubleshooting skills.
• Proficiency in process simulation software and data analysis tools is advantageous.
• Strong project management skills and experience leading cross-functional teams.
• Effective communication and interpersonal skills.
• Experience with automation and control systems in manufacturing environments.

Responsabilidades

• Develop, optimize, and validate pharmaceutical manufacturing processes to ensure efficiency, quality, and compliance.
• Troubleshoot and resolve process-related issues, identifying root causes and implementing effective corrective actions.
• Lead process improvement initiatives, including the implementation of new technologies and methodologies.
• Ensure all manufacturing processes adhere to GMP, safety, and environmental regulations.
• Prepare and review process validation protocols and reports.
• Collaborate with R&D, Quality Assurance, and Production teams to ensure seamless scale-up and technology transfer of new products.
• Monitor process performance using statistical process control (SPC) techniques and key performance indicators (KPIs).
• Develop and maintain Standard Operating Procedures (SOPs) for all manufacturing processes.
• Provide technical support and guidance to production personnel.
• Stay abreast of industry best practices and emerging technologies in pharmaceutical manufacturing.

Conhecimentos

GMP knowledge

7+ years experience

Process development

Process validation

Automation/Control systems

Statistical SPC

SOPs development

Data analysis

Formação académica

Bachelors/Masters in Chemical or Mechanical Eng

Ferramentas

Process simulation software

Data analysis tools

Descrição da oferta de emprego

About the Role

Our client, a prominent player in the pharmaceutical manufacturing sector, is seeking an experienced Senior Process Engineer to join their operations in **Klerksdorp, North West**. This role is integral to optimizing and maintaining the efficiency, safety, and quality of our pharmaceutical manufacturing processes. You will be responsible for troubleshooting process issues, implementing improvements, and ensuring that all operations comply with stringent GMP and regulatory standards. The ideal candidate will possess a strong engineering background, significant experience in pharmaceutical process development and validation, and a passion for driving operational excellence. This is a key position that requires strong analytical skills, problem-solving abilities, and effective collaboration with cross-functional teams.

Key Responsibilities

• Develop, optimize, and validate pharmaceutical manufacturing processes to ensure efficiency, quality, and compliance.
• Troubleshoot and resolve process-related issues, identifying root causes and implementing effective corrective actions.
• Lead process improvement initiatives, including the implementation of new technologies and methodologies.
• Ensure all manufacturing processes adhere to GMP, safety, and environmental regulations.
• Prepare and review process validation protocols and reports.
• Collaborate with R&D, Quality Assurance, and Production teams to ensure seamless scale-up and technology transfer of new products.
• Monitor process performance using statistical process control (SPC) techniques and key performance indicators (KPIs).
• Develop and maintain Standard Operating Procedures (SOPs) for all manufacturing processes.
• Provide technical support and guidance to production personnel.
• Stay abreast of industry best practices and emerging technologies in pharmaceutical manufacturing.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, or a related field.
• A minimum of 7 years of experience in process engineering within the pharmaceutical or related highly regulated industry.
• Proven experience in process development, optimization, and validation of pharmaceutical manufacturing processes (e.g., sterile manufacturing, solid dosage forms, API production).
• In-depth knowledge of GMP, FDA, and other relevant regulatory guidelines.
• Strong understanding of chemical/physical principles relevant to pharmaceutical manufacturing.
• Excellent analytical, problem-solving, and troubleshooting skills.
• Proficiency in process simulation software and data analysis tools is advantageous.
• Strong project management skills and experience leading cross-functional teams.
• Effective communication and interpersonal skills.
• Experience with automation and control systems in manufacturing environments.

Benefits

• Our client offers a competitive salary of ZAR per annum, along with a comprehensive benefits package including health insurance, retirement fund, and paid annual leave. This role is based in **Klerksdorp, North West**, and offers a fantastic opportunity for career advancement within a leading pharmaceutical manufacturer.