Lead Process Engineer - Pharmaceutical API Production

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

Benefits offered by this job

Remote work across South Africa

Comprehensive health insurance

Professional development allowance

Generous paid time off

Job summary

Placements24 is seeking a Lead Process Engineer to oversee API manufacturing processes in a fully remote role within South Africa. You will design, optimize, and validate processes to meet cGMP standards and regulatory requirements.

You will mentor engineers, collaborate with regulatory affairs and QA, and ensure data integrity for submissions in a remote, cross-functional environment.

Qualifications

• Bachelor's or Master's degree in Chemical Engineering or a related field.
• 10+ years of API process engineering experience in the pharmaceutical industry.
• In-depth knowledge of cGMP, process validation, and regulatory guidelines.
• Proven experience leading engineering teams and managing complex projects.
• Exceptional communication for remote collaboration.

Responsibilities

• Lead the design, development, and optimization of processes for API manufacturing.
• Ensure all processes comply with cGMP, FDA, and other regulatory requirements.
• Oversee process validation activities and ensure data integrity for regulatory submissions.
• Troubleshoot complex process issues and implement robust, sustainable solutions.
• Mentor and guide a team of process engineers, fostering continuous improvement and technical excellence.
• Collaborate with R&D, Quality Assurance, and Manufacturing in a remote setting.

Skills

Leadership

Remote collaboration

Analytical thinking

Problem solving

Communication

Education

Bachelor's or Master's in Chemical Engineering

Tools

Process modeling

Job description

About the Role

Our client is seeking an accomplished Lead Process Engineer to oversee and advance their pharmaceutical API production processes. This is a fully remote position, allowing you to leverage your expertise from anywhere within South Africa , contributing to a critical sector that impacts global health. You will lead the design, optimization, and validation of manufacturing processes, ensuring compliance with stringent Good Manufacturing Practices (GMP). This role demands exceptional technical leadership, a deep understanding of pharmaceutical chemistry, and a commitment to innovation and quality in a virtual collaboration environment. You will guide a team of engineers and work closely with regulatory affairs and quality assurance departments.

Key Responsibilities

• Lead the design, development, and optimization of processes for Active Pharmaceutical Ingredient (API) manufacturing.
• Ensure all processes comply with cGMP, FDA, and other relevant regulatory requirements.
• Oversee process validation activities and ensure data integrity for regulatory submissions.
• Troubleshoot complex process issues and implement robust, sustainable solutions.
• Mentor and guide a team of process engineers, fostering a culture of continuous improvement and technical excellence.
• Collaborate effectively with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, in a remote setting.

Requirements

• Bachelor's or Master's degree in Chemical Engineering or a related field.
• Minimum of 10 years of experience in process engineering within the pharmaceutical industry, with significant API experience.
• In-depth knowledge of cGMP, process validation, and regulatory guidelines.
• Proven experience in leading engineering teams and managing complex projects.
• Exceptional analytical, problem-solving, and communication skills for remote collaboration.
• Experience with process modeling and simulation is advantageous.

Benefits

• Highly attractive annual salary package.
• Full remote work flexibility across South Africa .
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and professional development allowance.
• Opportunity to lead critical projects in the pharmaceutical sector.