Pharmaceutical Process Engineer - Manufacturing Optimization

Placements24; United States; Hybrid; USD 54,000 - 91,000; Full time

Benefits offered by this job

Medical aid

Life insurance

Retirement annuity

Hybrid work arrangement

Job summary

Placements24 is seeking a Pharmaceutical Process Engineer to optimize manufacturing processes in a regulated pharma setting. You will lead scale-up efforts, validate processes (IQ/OQ/PQ), and collaborate across R&D, QA, and Production to ensure compliant, efficient operations.

The role emphasizes process design, troubleshooting, documentation, and staying current with industry best practices within a hybrid environment in South Africa.

Qualifications

• Bachelor's or Master's degree in Chemical or Mechanical Engineering.
• 5+ years of process engineering experience in pharma or a regulated industry.
• Strong knowledge of GMP, IQ/OQ/PQ validation, and regulatory requirements.
• Experience in process optimization, troubleshooting and scale-up.
• Familiar with unit operations such as granulation, blending, tablet filling.
• Excellent analytical and project management skills.
• Strong communication and teamwork abilities.

Responsibilities

• Analyze current pharmaceutical manufacturing processes to identify efficiency gains.
• Design, develop, and implement process modifications and new technologies.
• Lead process validation activities (IQ, OQ, PQ) and ensure regulatory compliance.
• Troubleshoot production issues, identify root causes, implement solutions.
• Develop and maintain SOPs, batch records, and technical reports.
• Collaborate with R&D, QA, and Production to transfer and scale processes.
• Ensure adherence to GMP, safety, and environmental regulations.
• Stay updated on new technologies and best practices in pharmaceutical manufacturing.
• Participate in process hazard analyses and risk assessments.
• Train production personnel on new or modified processes.

Skills

Process optimization

Scale-up

GMP compliance

IQ/OQ/PQ validation

Process simulation

Cross-functional collaboration

Project management

LEAN/Six Sigma

Troubleshooting

Education

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

Tools

Aspen Plus

CAD

Job description

About the Role

Our client, a leading pharmaceutical manufacturer renowned for its commitment to innovation and quality, is seeking a dynamic Pharmaceutical Process Engineer to enhance its manufacturing operations in Klerksdorp, North West . This crucial role will focus on optimizing existing production processes, implementing new technologies, and ensuring efficient, safe, and compliant manufacturing of high-quality pharmaceutical products. The engineer will be involved in process design, scale-up, validation, and troubleshooting, working closely with production, quality assurance, and R&D teams. This is an exceptional opportunity for a talented engineer to make a significant impact on manufacturing efficiency and product quality within a supportive and technologically advanced environment. The position offers a blend of hands-on engineering work and strategic planning, contributing directly to the company's success in Klerksdorp, North West .

Key Responsibilities

• Analyze current pharmaceutical manufacturing processes to identify areas for improvement in efficiency, yield, and cost-effectiveness.
• Design, develop, and implement process modifications and new manufacturing technologies.
• Lead process validation activities, including IQ, OQ, and PQ, ensuring compliance with regulatory standards.
• Troubleshoot production issues, identify root causes, and implement effective solutions.
• Develop and maintain process documentation, including SOPs, batch records, and technical reports.
• Collaborate with cross-functional teams (R&D, QA, Production) to ensure seamless process transfer and scale-up.
• Ensure manufacturing processes adhere to GMP, safety, and environmental regulations.
• Stay abreast of new technologies and industry best practices in pharmaceutical manufacturing.
• Participate in process hazard analyses and risk assessments.
• Train production personnel on new or modified processes.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, or a related discipline.
• Minimum of 5 years of experience in process engineering within the pharmaceutical or a related regulated industry (e.g., biopharmaceutical, food processing).
• Strong understanding of GMP, validation principles (IQ/OQ/PQ), and regulatory requirements.
• Proven experience in process optimization, troubleshooting, and scale-up.
• Proficiency in process simulation software (e.g., Aspen Plus) and CAD software is a plus.
• Excellent analytical, problem-solving, and project management skills.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.
• Familiarity with various pharmaceutical unit operations (e.g., granulation, blending, tablet compression, sterile filling).
• Ability to work effectively in both a lab/office environment and on the manufacturing floor.
• Knowledge of Lean Manufacturing or Six Sigma methodologies is advantageous.

Benefits

Our client offers a competitive salary package, complemented by performance-based incentives and a comprehensive benefits program including medical aid, life insurance, and a retirement annuity. This hybrid role allows for a flexible working arrangement, combining valuable on-site collaboration with the convenience of remote work days. We provide excellent opportunities for professional development, including access to specialized training, industry conferences, and career advancement pathways within the organization. Employees benefit from working with cutting-edge technology and a supportive team environment in Klerksdorp, North West . This is an opportunity to shape the future of pharmaceutical manufacturing for a reputable company.