Remote Lead API Process Engineer - GMP Manufacturing

Placements24; Stellenbosch; Hybrid; 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

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.