Remote Senior Process Engineer - Pharmaceutical Manufacturing

Placements24; Queenstown; Hybrid; NZD 170,000 - 250,000; Full time

Benefits offered by this job

Medical aid

Retirement provisions

Flexible remote arrangement

Job summary

Placements24 is seeking a Senior Process Engineer for a fully remote role in pharmaceutical manufacturing. You will lead process design, validate systems, and troubleshoot operations from anywhere within South Africa.

Expertise in cGMP, FDA regulations, and aseptic processing is highly valued. The ideal candidate will drive process optimization, scale-up, and technology evaluation while collaborating with R&D, QA, Manufacturing and Validation teams to ensure regulatory compliance and

Qualifications

• Senior process engineer with strong regulatory knowledge and track record in pharma.
• Expertise in process design, validation and troubleshooting in cGMP environments.
• Experience leading remote cross-functional teams on complex projects.

Responsibilities

• Lead process design, scale-up and optimization for pharmaceutical manufacturing equipment and systems.
• Develop and execute IQ/OQ/PQ validation protocols in line with cGMP and FDA guidelines.
• Troubleshoot complex process issues, identify root causes and implement CAPAs.
• Collaborate remotely with R&D, QA, Manufacturing and Validation teams.
• Ensure process modifications meet pharmaceutical standards and regulatory requirements.
• Prepare P&IDs, URS, PFDs and technical reports.
• Conduct PHA and risk assessments for new and existing processes.
• Evaluate new technologies to improve efficiency, quality and cost-effectiveness.
• Provide technical support and training to manufacturing personnel.

Skills

Analytical skills

Remote collaboration

Regulatory knowledge (FDA/cGMP)

Education

B.Eng or B.Sc in Chemical Engineering

Tools

Process simulation software

Job description

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.