Lead Process Development Engineer - Pharmaceuticals

Placements24; George; On-site; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Retirement savings plan with company 


Generous paid time off

Relocation assistance

Job summary

Placements24 is seeking a highly skilled Lead Process Development Engineer for its George, Western Cape facility. You will spearhead process optimization from lab scale to commercial production and lead a team of engineers and technicians dedicated to robust, compliant manufacturing.

You will drive process validation, troubleshoot complex issues, and implement continuous improvement with Lean Six Sigma, ensuring regulatory alignment with GMP and FDA standards.

Qualifications

• Bachelor's or Master's degree in Chemical or Mechanical Engineering or related field.
• Minimum 8 years of progressive experience in pharmaceutical process development and manufacturing.
• Proven experience in leading engineering teams and managing complex projects.
• In-depth knowledge of GMP, FDA, and other regulatory requirements.
• Strong understanding of unit operations relevant to pharmaceutical production (e.g., filtration, drying, milling, granulation).
• Experience with process simulation software and statistical analysis tools.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional leadership and communication abilities.

Responsibilities

• Lead design, development, and optimization of pharmaceutical processes from lab to commercial production.
• Manage and mentor a team of process engineers and technicians.
• Develop and implement process validation strategies ensuring regulatory compliance.
• Troubleshoot manufacturing issues, identify root causes, implement corrective actions.
• Conduct feasibility studies and technical assessments for new products and process changes.
• Collaborate with R&D, QA, and Manufacturing Operations teams.
• Author and review technical reports and SOPs.
• Drive continuous improvement using Lean Six Sigma methodologies.
• Oversee process safety assessments and compliance with HSE regulations.
• Manage external vendors and contractors for equipment installation and commissioning.

Skills

Leadership

Team mentoring

Project management

Problem solving

Communication

Lean Six Sigma

Regulatory knowledge

GMP knowledge

Aseptic processing familiarity

Education

Bachelor's or Master's in Chemical/Mechanical Engineering

Tools

Process simulation software

Statistical analysis tools

Job description

About the Role

Our client is seeking a highly skilled and motivated Lead Process Development Engineer to spearhead process optimization and scale-up activities within their state-of-the-art pharmaceutical manufacturing facility in George, Western Cape . This senior position is critical for ensuring the efficient, robust, and compliant production of vital pharmaceutical products. The successful candidate will lead a team of engineers and technicians, driving innovation in process design, troubleshooting manufacturing challenges, and implementing continuous improvement initiatives. This role demands a strong blend of technical expertise, leadership acumen, and a deep understanding of pharmaceutical manufacturing principles. You will play a key role in enhancing production capacity and efficiency, directly impacting the availability of essential medicines. This is a significant opportunity to shape manufacturing processes in a growing region and contribute to the pharmaceutical industry's advancement. The position requires a hands-on approach and a commitment to quality and safety in George .

Key Responsibilities

• Lead the design, development, and optimization of pharmaceutical manufacturing processes from lab scale to commercial production.
• Manage and mentor a team of process engineers and technicians, fostering a high-performance culture.
• Develop and implement process validation strategies, ensuring compliance with regulatory standards.
• Troubleshoot complex manufacturing issues, identifying root causes and implementing effective corrective actions.
• Conduct feasibility studies and technical assessments for new product introductions and process modifications.
• Collaborate closely with R&D, Quality Assurance, and Manufacturing Operations teams.
• Author and review technical reports, batch records, and Standard Operating Procedures (SOPs).
• Drive continuous improvement initiatives using methodologies such as Lean Six Sigma.
• Oversee process safety assessments and ensure adherence to all HSE regulations in George .
• Manage external vendors and contractors involved in process equipment installation and commissioning.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, or a related field.
• Minimum of 8 years of progressive experience in pharmaceutical process development and manufacturing.
• Proven experience in leading engineering teams and managing complex projects.
• In-depth knowledge of GMP, FDA, and other relevant regulatory requirements.
• Strong understanding of unit operations relevant to pharmaceutical production (e.g., filtration, drying, milling, granulation).
• Experience with process simulation software and statistical analysis tools.
• Excellent analytical, problem-solving, and decision-making skills.
• Exceptional leadership, communication, and team collaboration abilities.
• Demonstrated ability to manage multiple projects simultaneously and meet tight deadlines.
• Familiarity with cleanroom environments and aseptic processing is a significant advantage for this role in George .

Benefits

• Our client offers a competitive salary and a comprehensive benefits package, including health, dental, and vision insurance.
• We provide a retirement savings plan with company matching, generous paid time off, and opportunities for professional growth through training and development programs.
• A dynamic and challenging work environment awaits, along with the chance to lead critical manufacturing operations.
• Relocation assistance is available for successful candidates relocating to the beautiful George region.
• Be part of a company committed to improving health outcomes.