Lead Pharmaceutical Process Engineer

Placements24; Stellenbosch; On-site; ZAR 1,500,000 - 2,100,000; Full time

Benefits offered by this job

Medical aid

Retirement fund

Life insurance

Generous leave

Career development opportunities

Job summary

Placements24 is seeking a Lead Pharmaceutical Process Engineer to oversee and optimize manufacturing operations in Stellenbosch. You will lead a team of engineers, drive process improvements, validate processes, and ensure cGMP compliance at a state-of-the-art facility.

You will collaborate with R&D, QA, and maintenance, manage capital projects, and implement new technologies to support scalable production of high-quality pharmaceutical products on-site in Stellenbosch.

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or related field; Master’s preferred.
• 8+ years of progressive pharmaceutical process engineering experience, with 3+ years in leadership.
• Knowledge of aseptic processing, solid dosage forms, or lyophilization is ideal.
• Strong grasp of cGMP regulations, process validation, and regulatory submissions.

Responsibilities

• Lead, mentor, and develop a team of pharmaceutical process engineers.
• Design, implement, and optimize manufacturing processes for various dosage forms.
• Develop and execute process validation protocols per cGMP requirements.
• Troubleshoot deviations and implement CAPAs.
• Drive process improvements, efficiency gains, and cost reductions.
• Manage technology transfer activities for new products and processes.
• Ensure safety, environmental, and regulatory standards are met.
• Collaborate with R&D, QA, Manufacturing Operations, and Maintenance.

Skills

Process engineering

Leadership

Regulatory compliance

Data analysis

Education

Bachelor’s degree in Chemical/Mechanical Engineering

Master’s degree preferred

Tools

Engineering software

Job description

About the Role

Our client, a leading pharmaceutical manufacturing company, is seeking a highly skilled and experienced Lead Pharmaceutical Process Engineer to oversee and optimize manufacturing processes at their state-of-the-art facility in Stellenbosch. This critical role is responsible for ensuring the efficient, safe, and compliant production of high-quality pharmaceutical products. You will lead a team of process engineers, drive process improvements, implement new technologies, and troubleshoot complex manufacturing challenges. This position requires a deep understanding of pharmaceutical manufacturing principles, process validation, and regulatory requirements (cGMP). As this role is integral to the operational success of the manufacturing site, it is an on-site position based in Stellenbosch, demanding active engagement with production teams, quality assurance, and maintenance departments. Your expertise will be vital in maintaining operational excellence and supporting the company's growth.

Key Responsibilities

• Lead, mentor, and develop a team of pharmaceutical process engineers.
• Oversee the design, implementation, and optimization of pharmaceutical manufacturing processes for various dosage forms.
• Develop and execute process validation protocols and reports in compliance with cGMP.
• Troubleshoot manufacturing deviations and implement corrective and preventive actions (CAPAs).
• Identify opportunities for process improvements, efficiency gains, and cost reductions.
• Manage technology transfer activities for new products and processes.
• Ensure adherence to all safety, environmental, and regulatory standards.
• Collaborate with cross-functional teams, including R&D, Quality Assurance, Manufacturing Operations, and Maintenance.
• Stay abreast of industry best practices and new manufacturing technologies.
• Manage capital projects related to process equipment and facility upgrades.

Requirements

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related field; Master's degree preferred.
• Minimum of 8 years of progressive experience in pharmaceutical process engineering, with at least 3 years in a leadership role.
• Extensive knowledge of pharmaceutical manufacturing operations, including aseptic processing, solid dosage forms, or lyophilization.
• Strong understanding of cGMP regulations, process validation principles, and regulatory submission requirements.
• Proven experience in process optimization, scale-up, and technology transfer.
• Excellent analytical, problem-solving, and project management skills.
• Strong leadership, communication, and interpersonal skills for effective team and stakeholder management.
• Ability to work effectively in a fast-paced manufacturing environment.
• Proficiency in relevant engineering software and data analysis tools.

Benefits

Our client offers a highly competitive salary, performance-based bonuses, and a comprehensive benefits package including medical aid, retirement fund, life insurance, and generous leave. Employees benefit from extensive training programs, opportunities for career advancement within a global organization, and a supportive work environment at our Stellenbosch facility. This role is ideal for an experienced engineer looking to make a significant impact on pharmaceutical manufacturing operations.