Remote Senior Process Development Engineer - Pharmaceuticals

Placements24; Gqeberha; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Flexible remote work

Stock options

Comprehensive health benefits

Generous vacation policy

Job summary

Placements24 is seeking a Senior Process Development Engineer for a fully remote role in the biopharmaceutical sector. You will develop and optimize manufacturing processes for APIs, scale from lab to pilot to commercial production, and apply PAT/QbD to ensure robust processes.

The ideal candidate has a PhD/MS in Chemical or Biochemical Engineering, 6+ years in pharma/biotech process development, and strong cGMP knowledge. Remote collaboration with cross-functional teams is essential.

Qualifications

• Master's degree or PhD in Chemical Engineering, Biochemical Engineering, or related field.
• Minimum 6 years in process development and scale-up within pharma/biotech.
• Deep knowledge of cGMP regulations and their application to manufacturing.
• Experience with unit operations: reaction, crystallization, filtration, drying.
• Proficiency in process modeling and simulation software is a plus.
• Strong analytical skills and ability to develop/validate analytical methods.

Responsibilities

• Develop and optimize manufacturing processes for pharmaceutical intermediates and APIs.
• Scale up processes from lab to pilot plant and commercial scales.
• Conduct process characterization studies and establish CPPs.
• Utilize PAT and QbD principles in process development.
• Troubleshoot and resolve issues during process development and scale-up.
• Write process development reports, validation protocols, and batch records.
• Collaborate with R&D, QA, and Manufacturing Operations.
• Ensure activities comply with cGMP and internal standards.
• Contribute to selection/qualification of new equipment and technologies.

Skills

Process development

Scale-up

cGMP knowledge

Analytical method development

Remote work management

Education

Master's or PhD in Chemical/Biochemical Engineering

Tools

Process modeling software

Job description

About the Role

Our client, a rapidly growing biopharmaceutical company, is seeking a highly motivated Senior Process Development Engineer to join their innovative team. This is a fully remote position, offering the flexibility to work from anywhere. You will play a key role in the development and optimization of manufacturing processes for novel pharmaceutical products. This includes scaling up laboratory processes to pilot and commercial manufacturing, ensuring robust and reproducible outcomes. The ideal candidate will possess a strong background in chemical or biochemical engineering, extensive experience in process development within the pharmaceutical industry, and a proven ability to manage projects independently. You will leverage advanced process understanding and analytical techniques to drive efficiency and quality.

Key Responsibilities

• Develop and optimize manufacturing processes for pharmaceutical intermediates and active pharmaceutical ingredients (APIs).
• Scale up processes from laboratory to pilot plant and commercial manufacturing scales.
• Conduct process characterization studies and establish critical process parameters (CPPs).
• Utilize Process Analytical Technology (PAT) and Quality by Design (QbD) principles in process development.
• Troubleshoot and resolve technical issues encountered during process development and scale-up.
• Write comprehensive process development reports, validation protocols, and batch records.
• Collaborate effectively with cross-functional teams including R&D, Quality Assurance, and Manufacturing Operations.
• Ensure all activities comply with cGMP regulations and internal quality standards.
• Contribute to the selection and qualification of new manufacturing equipment and technologies.

Requirements

• Master's degree or PhD in Chemical Engineering, Biochemical Engineering, or a related field.
• Minimum of 6 years of experience in process development and scale-up within the pharmaceutical or biotechnology industry.
• Deep understanding of cGMP regulations and their application to manufacturing processes.
• Experience with common pharmaceutical unit operations (e.g., reaction, crystallization, filtration, drying).
• Proficiency in process modeling and simulation software is a plus.
• Strong analytical skills with experience in analytical method development and validation.
• Excellent written and verbal communication skills, with the ability to present complex information clearly.
• Demonstrated ability to work independently, manage multiple projects, and meet deadlines in a remote work environment.
• Experience with sterile processing or biologics manufacturing is highly desirable.

Benefits

Our client offers a competitive salary, comprehensive health benefits, stock options, a generous vacation policy, and a flexible remote work arrangement. You will have the opportunity to work on cutting-edge pharmaceutical projects with a talented and supportive team, contributing to the development of life-saving medicines from the comfort of your own home. This role is ideal for a proactive engineer seeking impactful work with maximum flexibility.