Senior Pharmaceutical Manufacturing Engineer

Placements24

Mossel Bay

On-site

ZAR 900,000 - 1,200,000

Full time

5 days ago
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Job summary

Placements24 in Mossel Bay, Western Cape, is seeking a Senior Pharmaceutical Manufacturing Engineer to optimize processes, validate equipment, and lead continuous improvement in a GMP environment. The role focuses on designing, implementing, and validating new manufacturing equipment and technologies, while troubleshooting complex operational issues.

You will collaborate with Quality Assurance, Production, R&D, and Maintenance to ensure seamless operations, develop SOPs, and drive lean

Qualifications

  • Bachelor's degree in Chemical or Mechanical Engineering or Pharmaceutical Technology, or an equivalent field.
  • Master's degree is a plus.
  • 5–8 years of experience in pharmaceutical manufacturing or process engineering.
  • Experience in design, validation, troubleshooting of pharma manufacturing equipment.
  • Strong GMP knowledge and familiarity with regulatory guidelines.
  • Experience with process automation and Lean/Six Sigma methodologies.
  • Excellent analytical, problem-solving, and communication skills.

Responsibilities

  • Design, develop, install, and commission new pharma manufacturing equipment and systems.
  • Optimize existing processes to boost efficiency, yield, and quality while reducing waste and costs.
  • Develop and execute IQ/OQ/PQ validation protocols for equipment and processes.
  • Troubleshoot complex technical issues related to equipment and processes.
  • Lead process improvement projects using Lean and Six Sigma methodologies.
  • Ensure GMP compliance and other regulatory requirements across activities.
  • Collaborate with QA, Production, R&D, and Maintenance to ensure seamless operations.
  • Develop SOPs and train manufacturing personnel.
  • Analyze production data to identify trends and root causes for improvements.

Skills

Lean Six Sigma
GMP knowledge
Regulatory compliance
Analytical problem-solving
Technical writing
Project management
Process automation

Education

Bachelor's degree in Chemical Engineering
Bachelor's degree in Mechanical Engineering
Bachelor's degree in Pharmaceutical Technology
Master's degree (advantage)

Tools

CAD
Simulation software
Control systems software

Job description

About the Role

Our client, a global leader in pharmaceutical manufacturing, is seeking a highly skilled and experienced Senior Pharmaceutical Manufacturing Engineer to join their state-of-the-art facility in Mossel Bay, Western Cape . This pivotal role will focus on optimizing manufacturing processes, ensuring efficient production, and driving continuous improvement initiatives within the plant. The successful candidate will be responsible for designing, implementing, and validating new manufacturing equipment and technologies, as well as troubleshooting complex operational issues. We are looking for a proactive and analytical engineer with a deep understanding of pharmaceutical production environments, GMP regulations, and process automation. This is an exciting opportunity to contribute to the manufacturing of high-quality pharmaceuticals in a scenic coastal location. The engineer will play a key role in enhancing productivity, reducing costs, and maintaining the highest standards of quality and safety in our Mossel Bay operations.

Key Responsibilities
  • Design, develop, install, and commission new pharmaceutical manufacturing equipment and systems.
  • Optimize existing manufacturing processes to improve efficiency, yield, and product quality, while minimizing waste and costs.
  • Develop and execute validation protocols (IQ, OQ, PQ) for new and modified equipment and processes.
  • Troubleshoot and resolve complex technical issues related to manufacturing equipment and processes.
  • Lead and participate in process improvement projects using methodologies such as Lean Manufacturing and Six Sigma.
  • Ensure all manufacturing activities comply with Good Manufacturing Practices (GMP) and other relevant regulatory requirements.
  • Collaborate with cross-functional teams, including Quality Assurance, Production, R&D, and Maintenance, to ensure seamless operations.
  • Develop Standard Operating Procedures (SOPs) and provide training to manufacturing personnel.
  • Analyze production data to identify trends, root causes of problems, and opportunities for improvement.
  • Stay current with advancements in pharmaceutical manufacturing technologies and best practices.
Requirements
  • Bachelor's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Technology, or a related field.
  • A Master's degree is a plus.
  • Minimum of 5-8 years of experience in pharmaceutical manufacturing, process engineering, or a similar role within the pharmaceutical industry.
  • Proven experience in process design, optimization, validation, and troubleshooting of pharmaceutical manufacturing equipment (e.g., reactors, filtration systems, lyophilizers, packaging lines).
  • Strong knowledge of GMP, FDA, EMA, and other relevant regulatory guidelines.
  • Experience with process automation and control systems.
  • Proficiency in project management and Lean/Six Sigma methodologies.
  • Excellent analytical, problem-solving, and decision-making skills.
  • Strong technical writing and communication skills.
  • Ability to work effectively in a fast-paced manufacturing environment and collaborate with diverse teams.
  • Proficiency in relevant engineering software (e.g., CAD, simulation software).
Benefits

Our client offers an attractive salary package, comprehensive medical and retirement benefits, performance incentives, and significant opportunities for career advancement within a leading pharmaceutical organization. Relocation assistance may be available. This position is based at our modern facility in Mossel Bay, Western Cape . We are committed to fostering a culture of innovation, safety, and operational excellence, making this an ideal role for a motivated manufacturing engineer seeking to make a substantial impact.

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