Senior Pharmaceutical Process Engineer (Remote)

Placements24; Mossel Bay; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Annual bonus

Health insurance

Retirement plan

Paid time off

Remote tools

Remote work

Job summary

Placements24, a global pharmaceutical leader, seeks a Senior Pharmaceutical Process Engineer to drive design, development, optimization, and scale-up of manufacturing processes in a remote-first role within South Africa. You will collaborate with R&D, QA, and production teams to implement robust processes.

The ideal candidate holds an MSc or PhD in Chemical or Pharmaceutical Engineering, with 7+ years in pharma, strong knowledge of cGMP and regulatory guidelines, and experience with Aspen Plus

Qualifications

• MSc or PhD in Chemical or Pharmaceutical Engineering.
• 7+ years in pharmaceutical process development, scale-up and manufacturing.
• Knowledge of cGMP, ICH guidelines, and regulatory submissions.
• Experience with aseptic processing is highly desirable.

Responsibilities

• Design, develop, and optimize manufacturing processes for scale-up.
• Lead IQ/OQ/PQ activities and analyze raw data.
• Support technology transfer across units.
• Develop and maintain SOPs for manufacturing processes.
• Conduct process hazard analyses and implement safety measures.
• Prepare detailed technical reports for stakeholders.

Skills

Process engineering

Project management

Leadership

Communication skills

Data analysis

Education

M.Sc. or Ph.D. in Chemical/Pharmaceutical Engineering

Tools

Aspen Plus

Job description

About the Role

Our client, a global leader in the pharmaceutical industry, is seeking a highly skilled Senior Pharmaceutical Process Engineer to join their innovative and fully remote team. This critical role will focus on the design, development, optimization, and scale-up of pharmaceutical manufacturing processes. You will leverage your expertise in chemical engineering principles and pharmaceutical manufacturing technologies to enhance efficiency, quality, and cost-effectiveness across various production lines. This is a remote-first position, allowing you to contribute from anywhere within South Africa. You will collaborate closely with manufacturing, quality assurance, and research and development departments to ensure seamless process implementation and continuous improvement. Our client is dedicated to advancing pharmaceutical manufacturing through technological innovation and sustainable practices. We offer a comprehensive remote work infrastructure to support your success.

Key Responsibilities

• Design, develop, and optimize pharmaceutical manufacturing processes for new and existing products, ensuring scalability and robustness.
• Lead process validation activities, including IQ, OQ, PQ, and raw data analysis.
• Troubleshoot and resolve complex process-related issues encountered during manufacturing.
• Conduct process hazard analyses and implement safety measures.
• Develop and maintain Standard Operating Procedures (SOPs) for manufacturing processes.
• Collaborate with R&D and manufacturing teams on technology transfer and scale-up initiatives.
• Utilize process simulation and modeling software to predict and optimize process performance.
• Stay current with industry best practices, new technologies, and regulatory requirements (e.g., FDA, EMA, SAHPRA).
• Prepare detailed technical reports, documentation, and presentations for internal and external stakeholders.
• Contribute to cost reduction initiatives through process improvement and waste minimization.

Requirements

• M.Sc. or Ph.D. in Chemical Engineering, Pharmaceutical Engineering, or a related field.
• Minimum of 7 years of experience in pharmaceutical process development, scale-up, and manufacturing.
• In-depth knowledge of pharmaceutical manufacturing equipment, processes (e.g., granulation, drying, sterile filling), and technologies.
• Strong understanding of cGMP, ICH guidelines, and regulatory submission requirements.
• Proven experience in process validation and optimization.
• Proficiency in process simulation software (e.g., Aspen Plus) and data analysis tools.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong project management and leadership abilities.
• Exceptional communication and interpersonal skills, with the ability to collaborate effectively in a remote team environment.
• Experience with aseptic processing and sterile drug product manufacturing is highly desirable.

Benefits

• Highly competitive salary package and potential for annual bonuses.
• Comprehensive health, dental, and vision insurance.
• Generous retirement savings plan.
• Significant paid time off and opportunities for continuous learning.
• Access to cutting-edge digital tools and resources for remote work.
• Opportunity to influence the future of pharmaceutical manufacturing.
• Fully remote work flexibility.