Process Development Engineer - Pharmaceutical Manufacturing

Placements24

Klerksdorp

On-site

ZAR 900,000 - 1,200,000

Full time

2 days ago
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Benefits offered by this job

Competitive salary
Medical coverage
Annual leave
Professional development
Retirement plan
Modern manufacturing facility
Career growth opportunities

Job summary

Placements24 invites applications for a Process Development Engineer in Klerksdorp to optimize and scale pharmaceutical manufacturing processes, including granulation, blending, tablet compression, coating and sterile filling, ensuring quality, efficiency and regulatory compliance.

The role requires a Bachelor's degree in Chemical or Mechanical Engineering, at least 5 years of pharma process development experience, GMP knowledge, hands-on process equipment exposure, and strong teamwork with R&D,

Qualifications

  • Bachelor's degree in Chemical or Mechanical Engineering required.
  • Minimum 5 years' experience in pharmaceutical process development.
  • Strong GMP knowledge, IQ/OQ/PQ and validation experience.
  • Hands‑on experience with process equipment and instrumentation.
  • Excellent problem‑solving, analytical and critical thinking skills.

Responsibilities

  • Develop, optimize, and scale-up pharmaceutical manufacturing processes (granulation, blending, tablet compression, coating, sterile filling).
  • Design and execute experiments to define process parameters and operating ranges.
  • Perform process validation activities (IQ, OQ, PQ).
  • Troubleshoot manufacturing issues and improve yield.
  • Collaborate with R&D, QA, and Production for technology transfer and implementation.
  • Author process development and validation reports; contribute to regulatory filings.
  • Ensure compliance with GMP, safety, and environmental regulations.
  • Identify opportunities for process improvement and cost reduction.
  • Evaluate and recommend new manufacturing technologies and equipment.
  • Maintain detailed records of all process development activities.

Skills

GMP principles
Process development
Project management
Problem solving
Analytical thinking
Interdepartmental collaboration
SPC
Lean manufacturing
Process modeling software

Education

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

Tools

Process simulation software

Job description

About the Role

Our client, a distinguished leader in the pharmaceutical manufacturing sector, is seeking a skilled Process Development Engineer to join their operations in Klerksdorp, North West . This role is pivotal in optimizing and scaling up pharmaceutical manufacturing processes to ensure efficiency, quality, and cost-effectiveness. You will be responsible for the development, validation, and continuous improvement of manufacturing processes for various pharmaceutical products. The ideal candidate possesses a strong engineering background, hands‑on experience with manufacturing equipment, and a deep understanding of GMP principles. Join a forward-thinking company dedicated to producing high-quality pharmaceuticals and contributing to improved patient outcomes. This is an excellent opportunity to make a significant impact in a dynamic manufacturing environment in Klerksdorp.

Key Responsibilities
  • Develop, optimize, and scale-up pharmaceutical manufacturing processes, including granulation, blending, tablet compression, coating, and sterile filling.
  • Design and execute experiments to define process parameters and operating ranges.
  • Perform process validation activities, including IQ, OQ, and PQ protocols.
  • Troubleshoot manufacturing issues and implement effective solutions to minimize downtime and improve yield.
  • Collaborate with R&D, Quality Assurance, and Production teams to ensure seamless technology transfer and process implementation.
  • Author process development reports, validation reports, and relevant sections of regulatory filings.
  • Ensure all process development activities comply with GMP, safety, and environmental regulations.
  • Identify opportunities for process improvement and cost reduction initiatives.
  • Evaluate and recommend new manufacturing technologies and equipment.
  • Maintain accurate and detailed records of all process development activities.
Requirements
  • Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related field.
  • A Master's degree is a plus.
  • Minimum of 5 years of experience in process development and scale-up within the pharmaceutical or biopharmaceutical industry.
  • Proven experience with various pharmaceutical manufacturing operations (e.g., solid dosage, sterile manufacturing).
  • Strong understanding of GMP, validation principles (IQ/OQ/PQ), and regulatory requirements.
  • Hands‑on experience with process equipment and instrumentation.
  • Excellent problem‑solving, analytical, and critical thinking skills.
  • Proficiency in process simulation and modeling software is desirable.
  • Strong project management and organizational skills.
  • Effective communication and interpersonal skills, with the ability to work collaboratively across departments.
  • Detail‑oriented with a commitment to quality and safety.
  • Experience with statistical process control (SPC) is an advantage.
  • Familiarity with lean manufacturing principles.
Benefits
  • Our client provides a competitive salary package, commensurate with experience, along with opportunities for performance‑based bonuses.
  • Comprehensive medical coverage, including hospital plans and specialist consultations, is offered.
  • A generous annual leave policy and paid sick leave contribute to employee well‑being.
  • Professional development opportunities, such as specialized training courses and industry conferences, are encouraged and supported.
  • Employees are enrolled in a retirement savings fund with employer contributions.
  • The role is based in Klerksdorp, offering a chance to work in a modern manufacturing facility with advanced technology and a supportive team culture.
  • Our client is committed to fostering career growth and offers clear advancement opportunities within the pharmaceutical manufacturing sector.
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