Process Development Engineer - Pharmaceuticals

Placements24; Mbombela (Nelspruit); Hybride; ZAR 1 000 000 - 1 800 000; Plein temps

Avantages offerts par ce poste

Remote work

Competitive salary

Flexible benefits

Résumé du poste

Placements24 is seeking a Process Development Engineer to advance pharmaceutical manufacturing processes remotely across South Africa. You will develop, optimize and scale processes for APIs, ensuring quality, efficiency, and regulatory compliance throughout development.

Flexibility and strong documentation skills are required. Design experiments to characterize parameters, perform IQ/OQ/PQ validations, and troubleshoot deviations.

Qualifications

• Master's or Ph.D. in Chemical Engineering or related field.
• 6+ years of process development and scale-up experience in pharma.
• Strong knowledge of GMP regulations and process validation.
• Proficiency in process simulation and modeling software.
• Excellent analytical, problem-solving, and documentation skills.
• Ability to work independently in a remote environment.

Responsabilités

• Develop and optimize manufacturing processes for pharmaceutical intermediates and APIs.
• Design experiments to characterize process parameters and establish operating ranges.
• Scale up processes from lab to pilot and commercial scale with reproducibility.
• Conduct IQ, OQ, and PQ validation activities.
• Troubleshoot deviations and implement corrective actions (CAPAs).
• Prepare technical reports and regulatory submission documents.
• Ensure GMP compliance in all activities.

Connaissances

Process development

Scale-up

GMP knowledge

Data interpretation

Technical documentation

Remote work management

Formation

Master's or Ph.D. in Chemical Engineering

Outils

Process simulation software

Description du poste

About the Role

Our client, a leading pharmaceutical company at the forefront of drug development, is seeking a talented Process Development Engineer to join their innovative team. This is a fully remote position, offering flexibility and the opportunity to contribute to critical pharmaceutical manufacturing processes from anywhere in South Africa. You will play a pivotal role in developing, optimizing, and scaling up manufacturing processes for novel pharmaceutical products, ensuring quality, efficiency, and compliance with stringent regulatory standards. The ideal candidate possesses a strong background in chemical engineering principles applied to pharmaceutical manufacturing, with expertise in process design, validation, and troubleshooting. If you are a self-motivated engineer passionate about improving healthcare through advanced manufacturing technologies and thrive in a remote work setting, this role is an excellent fit. We are committed to leveraging technology to enhance pharmaceutical production and patient outcomes.

Key Responsibilities

• Develop and optimize manufacturing processes for pharmaceutical intermediates and active pharmaceutical ingredients (APIs).
• Design and execute experiments to characterize process parameters and establish operating ranges.
• Scale up processes from laboratory to pilot and commercial scale, ensuring robust and reproducible manufacturing.
• Perform process validation activities, including IQ, OQ, and PQ.
• Troubleshoot process deviations and implement effective corrective and preventive actions (CAPAs).
• Collaborate with formulation scientists, analytical chemists, and manufacturing personnel.
• Prepare detailed technical reports, validation protocols, and regulatory submission documents.
• Ensure all activities comply with Good Manufacturing Practices (GMP) and other relevant regulatory requirements.
• Evaluate and implement new process technologies to improve efficiency and product quality.
• Contribute to the continuous improvement of existing manufacturing processes.

Requirements

• Master's or Ph.D. in Chemical Engineering or a related field.
• Minimum of 6 years of experience in process development and scale-up within the pharmaceutical or biopharmaceutical industry.
• Strong understanding of chemical reaction engineering, thermodynamics, and separation processes relevant to pharmaceuticals.
• Proven experience with process validation and GMP regulations.
• Proficiency in process simulation and modeling software.
• Excellent analytical, problem-solving, and data interpretation skills.
• Strong written and verbal communication skills, with experience in technical documentation.
• Ability to work independently and manage projects effectively in a remote environment.
• Experience with continuous manufacturing technologies is a plus.
• Familiarity with Quality by Design (QbD) principles.

Benefits

This fully remote Process Development Engineer role offers a highly competitive salary and a comprehensive benefits package, including premium health, dental, and vision coverage, a generous retirement savings plan, and performance bonuses. We support work-life balance with flexible remote working arrangements and ample paid time off. Opportunities for professional development, including attendance at industry conferences and advanced training, are readily available. Our client is dedicated to fostering a culture of innovation and provides access to state-of-the-art research and development resources. Join a mission-driven company that is making a difference in global health. This position, while based out of Nelspruit, Mpumalanga (remote), offers significant career growth and the chance to be part of groundbreaking pharmaceutical advancements.