Remote Pharmaceutical Process Development Engineer

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

Benefits offered by this job

Health insurance

Retirement plan

Remote work environment

Job summary

Placements24 is seeking a Remote Pharmaceutical Process Development Engineer to design, optimize, and scale-up manufacturing processes for novel products. This remote-first role allows contributions from anywhere in South Africa.

You will translate lab-scale processes to commercial production while ensuring cGMP compliance and high quality standards. The candidate should have 6+ years of hands-on experience in pharmaceutical process development, strong knowledge of dosage forms, and expertise in

Qualifications

• Bachelor's or master's degree in Chemical Engineering, Pharmaceutical Engineering, or related field.
• Minimum 6 years of hands-on experience in pharmaceutical process development and scale-up.
• Strong understanding of various pharmaceutical dosage forms (solid, sterile, biologics).
• Proficiency in process modeling and simulation software.
• Experience with technology transfer activities and validation protocols (IQ, OQ, PQ).
• In-depth knowledge of cGMP regulations and pharmaceutical manufacturing principles.
• Excellent problem-solving, analytical, and communication skills.

Responsibilities

• Design, develop, and optimize pharmaceutical manufacturing processes (formulation, sterile, lyophilization).
• Conduct process development studies, including risk assessments and feasibility analyses.
• Scale-up from lab to pilot and commercial scales.
• Develop and validate CPPs and CQAs.
• Prepare technical reports and regulatory submission documents.
• Collaborate with R&D, Manufacturing, QA, and Regulatory Affairs.

Skills

SPC

DOE

Problem-solving

Remote collaboration

Education

Bachelor's or Master's in Chemical/Pharmaceutical Engineering

Tools

Process modeling software

Job description

About the Role

Our client is actively seeking a highly skilled and experienced Remote Pharmaceutical Process Development Engineer to join their dedicated team. This is a remote-first opportunity, allowing you to contribute your expertise from anywhere within South Africa. You will be responsible for the design, optimization, and scale-up of manufacturing processes for novel pharmaceutical products. This role is critical in ensuring that processes are robust, efficient, and compliant with all relevant industry regulations and quality standards. We are looking for an innovative engineer with a deep understanding of pharmaceutical manufacturing technologies and a proven ability to translate laboratory-scale processes to commercial production. Your work will directly impact the timely delivery of life-changing medications.

Key Responsibilities

• Design, develop, and optimize pharmaceutical manufacturing processes (e.g., formulation, sterile manufacturing, lyophilization).
• Conduct process development studies, including risk assessments and feasibility analyses.
• Scale-up processes from laboratory bench to pilot plant and commercial manufacturing scales.
• Develop and validate critical process parameters (CPPs) and critical quality attributes (CQAs).
• Prepare technical reports, process descriptions, and regulatory submission documents.
• Collaborate with cross-functional teams including R&D, Manufacturing, Quality Assurance, and Regulatory Affairs.
• Troubleshoot and resolve process-related issues during development and manufacturing phases.
• Evaluate and implement new process technologies and equipment.
• Ensure all process development activities comply with cGMP and other relevant regulatory requirements.
• Maintain detailed documentation of all experimental work and process development activities.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, or a related field.
• Minimum of 6 years of hands-on experience in pharmaceutical process development and scale-up.
• Strong understanding of various pharmaceutical dosage forms (e.g., solid dosage, sterile injectables, biologics).
• Proficiency in process modeling and simulation software.
• Experience with technology transfer activities and validation protocols (IQ, OQ, PQ).
• In-depth knowledge of cGMP regulations and pharmaceutical manufacturing principles.
• Excellent problem-solving, analytical, and critical thinking skills.
• Strong written and verbal communication skills, effective for remote collaboration.
• Ability to work independently and manage projects with minimal supervision.
• Familiarity with statistical process control (SPC) and Design of Experiments (DOE).

Benefits

This fully remote position offers a competitive salary commensurate with experience, comprehensive benefits including health insurance and retirement plan, and significant opportunities for professional development. Our client provides a supportive and collaborative remote work environment, encouraging innovation and career advancement. Join a leading pharmaceutical company and make a tangible impact from the comfort of your home office in Durban or anywhere else in South Africa.