Senior Pharmaceutical Process Development Engineer - Remote

Placements24; Randburg; Hybrid; ZAR 180,000 - 240,000; Full time

Benefits offered by this job

Remote work

Home office setup support

Competitive salary and performance bon

Benefits package including health

Job summary

Placements24 is seeking a Senior Pharmaceutical Process Development Engineer for a fully remote role. You will drive the design, optimization, and scale-up of manufacturing processes for novel drug candidates with emphasis on CPPs, CQAs, and technology transfer.

Ideal candidates bring 7–10 years in pharmaceutical process development, strong GMP knowledge, and capability to translate lab-scale processes to commercial manufacturing in a remote, cross-functional setting.

Qualifications

• Bachelor's or Master's degree in Chemical, Mechanical or Pharmaceutical Engineering or related field.
• 7–10 years of progressive pharmaceutical process development and scale-up experience.
• Strong knowledge of regulatory guidelines (ICH, FDA) for pharmaceutical manufacturing.

Responsibilities

• Lead development and optimization of scalable manufacturing processes for drug substances/products.
• Design experiments to understand CPPs and CQAs and develop process models.
• Support technology transfer from R&D to manufacturing at scale.
• Troubleshoot process-related issues during development and commercial manufacturing.
• Prepare process development reports, validation protocols, and regulatory submissions.
• Collaborate with Formulation, Analytical Development, Manufacturing Operations, and QA.

Skills

Process development

Scale-up

GMP knowledge

Regulatory understanding

SPC

Education

Bachelor's or Master's in Chemical Engineering

Tools

Aspen Plus

JMP

Minitab

Job description

About the Role

Our client, a leader in pharmaceutical innovation, is actively seeking a highly experienced Senior Pharmaceutical Process Development Engineer for a fully remote position. This role is pivotal in the design, optimization, and scale-up of manufacturing processes for novel pharmaceutical products. You will be instrumental in ensuring that our client's innovative drug candidates can be manufactured efficiently, reliably, and to the highest quality standards. The ideal candidate possesses a strong engineering background, extensive experience in pharmaceutical process development, and a proven ability to translate laboratory-scale processes to commercial manufacturing. You will collaborate with research, development, manufacturing, and quality teams to overcome complex technical challenges and ensure regulatory compliance. This remote position requires exceptional self-management, communication skills, and the ability to contribute significantly to project success without direct on-site supervision. You will drive process innovation and ensure our client's manufacturing capabilities remain state-of-the art, supporting their mission to deliver life-changing medicines to patients worldwide.

Key Responsibilities

• Lead the development and optimization of robust and scalable manufacturing processes for pharmaceutical drug substances and/or drug products.
• Design and execute experiments to understand process parameters, critical process parameters (CPPs), and critical quality attributes (CQAs).
• Develop process models and simulations to predict process performance and identify areas for improvement.
• Conduct technology transfer activities from R&D to manufacturing, ensuring successful implementation at scale.
• Troubleshoot and resolve complex process-related issues encountered during development, scale-up, and commercial manufacturing.
• Author and review process development reports, validation protocols, and regulatory submission documents (e.g., CMC sections).
• Collaborate with cross-functional teams, including Formulation, Analytical Development, Manufacturing Operations, and Quality Assurance.
• Ensure all process development activities comply with relevant GMP guidelines and regulatory requirements.
• Evaluate and recommend new technologies and equipment to enhance manufacturing capabilities.
• Mentor junior engineers and provide technical guidance on process development best practices.
• Manage project timelines and resources effectively to meet company objectives.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Mechanical Engineering, Pharmaceutical Engineering, or a related discipline.
• Minimum of 7-10 years of progressive experience in pharmaceutical process development and scale-up.
• Deep understanding of pharmaceutical manufacturing principles, unit operations, and associated equipment.
• Proven experience in process validation, technology transfer, and GMP environments.
• Strong knowledge of regulatory guidelines (e.g., ICH, FDA) pertaining to pharmaceutical manufacturing.
• Expertise in process modeling, simulation, and statistical process control (SPC) is highly desirable.
• Excellent analytical, problem-solving, and critical thinking skills.
• Exceptional written and verbal communication skills, with the ability to present complex technical information clearly.
• Proven ability to lead projects and collaborate effectively in a cross-functional, remote team setting.
• Proficiency in relevant software tools (e.g., Aspen Plus, JMP, Minitab) is advantageous.
• Demonstrated ability to work independently and drive results in a remote work environment.

Benefits

• Our client offers a highly competitive salary and a comprehensive benefits package, including excellent health, dental, and vision insurance, a strong retirement plan, and annual performance bonuses.
• Our client provides resources for home office setup to ensure you have a productive and comfortable working environment.
• Career advancement opportunities within their global operations are readily available for high achievers.