Remote Senior Process Engineer - Pharmaceutical Manufacturing

Placements24; Lorenziberg; Teletrabalho; EUR 64 000 - 96 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical aid

Retirement provisions

Remote work flexibility

Queenstown location flexibility

Resumo da oferta

Placements24 seeks a Senior Process Engineer for a fully remote role supporting pharmaceutical manufacturing. You will lead design, scale-up, and optimization of processes, develop validation protocols and ensure compliance with cGMP and FDA standards.

Remote collaboration with cross‑functional teams across regions is essential. The ideal candidate brings 7+ years in pharma process engineering, strong analytical skills, and experience with aseptic processing and cleanrooms.

Qualificações

• Bachelor degree in chemical engineering or related field.
• 7+ years of pharmaceutical process engineering experience.
• Strong knowledge of cGMP and FDA regulations.
• Experience with unit operations used in pharma manufacturing.
• Proficiency in process simulation and design software.
• Excellent communication for remote collaboration.

Responsabilidades

• Lead process design, scale-up and optimization for pharma manufacturing equipment and systems.
• Develop and execute IQ/OQ/PQ process validation protocols per regulatory guidelines.
• Troubleshoot complex process issues, identify root causes and implement CAPAs.
• Collaborate remotely with R&D, QA, Manufacturing and Validation teams.
• Ensure modifications meet regulatory standards for pharma processing.
• Prepare P&IDs, URS, PFDs and technical reports.
• Conduct PHAs and risk assessments for new/existing processes.
• Evaluate and implement new technologies to boost efficiency and quality.
• Provide technical support and training to manufacturing personnel.
• Stay updated on industry trends and regulatory changes.

Conhecimentos

Process engineering

cGMP knowledge

FDA regulations

Analytical ability

Remote collaboration

Project management

Problem-solving

Communication

Aseptic processing

Formação académica

B.Eng. or B.Sc. in Chemical Engineering

Ferramentas

Process simulation software

Descrição da oferta de emprego

About the Role

Our client, a globally recognized pharmaceutical company renowned for its commitment to innovation and quality, is seeking a highly skilled Senior Process Engineer to join their dynamic team on a fully remote basis. This pivotal role involves leading process design, optimization, and troubleshooting initiatives for pharmaceutical manufacturing operations. You will be instrumental in ensuring compliance with stringent regulatory standards (cGMP, FDA), enhancing process efficiency, and implementing state-of-the-art technologies. The ideal candidate will possess a deep understanding of pharmaceutical production processes, validation, and regulatory requirements, coupled with strong analytical and problem-solving skills. This is an exceptional opportunity to apply your expertise in a remote-first capacity, contributing to the development and manufacturing of life-saving medicines from anywhere within South Africa , including Queenstown .

Key Responsibilities

• Lead process design, scale-up, and optimization projects for pharmaceutical manufacturing equipment and systems.
• Develop and execute process validation protocols (IQ, OQ, PQ) in compliance with cGMP and regulatory guidelines.
• Troubleshoot complex process issues, identify root causes, and implement effective corrective and preventive actions (CAPAs).
• Collaborate remotely with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Validation departments.
• Ensure all process modifications and designs meet stringent pharmaceutical industry standards and regulatory requirements.
• Prepare detailed process documentation, including P&IDs, URS, PFDs, and technical reports.
• Conduct Process Hazard Analyses (PHAs) and risk assessments for new and existing processes.
• Evaluate and implement new technologies to improve process efficiency, product quality, and cost-effectiveness.
• Provide technical support and training to manufacturing personnel as needed.
• Stay current with industry trends, best practices, and regulatory changes in pharmaceutical manufacturing.

Requirements

• B.Eng. or B.Sc. in Chemical Engineering or a related field.
• Minimum of 7 years of experience in process engineering within the pharmaceutical industry.
• In-depth knowledge of cGMP, FDA regulations, and pharmaceutical process validation principles.
• Proven experience with unit operations common in pharmaceutical manufacturing (e.g., filtration, drying, granulation, sterile filling).
• Proficiency in process simulation and design software.
• Strong analytical and problem-solving abilities.
• Excellent communication, documentation, and interpersonal skills for remote collaboration.
• Demonstrated ability to manage projects and work independently in a remote setting.
• Experience with aseptic processing and cleanroom environments is a plus.
• Must have legal authorization to work remotely from South Africa.

Benefits

• Our client offers a competitive salary, comprehensive benefits package including medical aid and retirement provisions, and a flexible remote working arrangement.
• You will have the opportunity to work on impactful projects that contribute to global health and well-being.
• Professional development and continuous learning are strongly encouraged.
• Join a leading pharmaceutical organization that values expertise, innovation, and a commitment to quality, with the flexibility to work from Queenstown or any other location within South Africa.