Process Development Engineer (Pharmaceuticals)

Placements24; Queenstown; On-site; NZD 110,000 - 160,000; Full time

Benefits offered by this job

Medical aid

Retirement savings plan

Performance incentives

Professional development

Job summary

Placements24 seeks a Process Development Engineer to optimize pharmaceutical production processes in Queenstown. You will translate lab-scale processes to commercial-scale production, ensure quality and compliance, and collaborate across R&D, QA, and manufacturing.

The role requires strong problem-solving, project management, and experience with unit operations and process validation in a regulated environment.

Qualifications

• Bachelor’s degree in Chemical or Mechanical Engineering or related field.
• Experience in process development and scale-up in pharma or regulated industry is required.
• Strong knowledge of cGMP and process validation principles.
• Experience with unit operations like filtration, drying, mixing, and granulation is preferred.
• Excellent written and verbal communication for documentation and teamwork.

Responsibilities

• Design, develop, and optimize pharmaceutical manufacturing processes for scalability and robustness.
• Conduct process validation studies ensuring products meet specifications.
• Troubleshoot process issues during scale-up and commercial manufacturing.
• Collaborate with R&D to transfer lab-scale processes to pilot and full-scale production.
• Develop and implement process improvements for efficiency, yield, and cost reduction.
• Prepare batch records, SOPs, and validation protocols.
• Ensure compliance with cGMP, safety, and environmental standards.
• Evaluate new technologies or equipment to enhance capabilities.
• Provide technical support to manufacturing teams in Queenstown.

Skills

Process development

Scale-up

cGMP knowledge

Regulatory guidelines

Analytical problem solving

Project management

Communication

Education

Bachelor's degree in Chemical Engineering or Mechanical Engineering

Tools

Process modeling software

Job description

About the Role Our client, a leading pharmaceutical manufacturer, is seeking a highly skilled Process Development Engineer to join their operations in Queenstown, Eastern Cape. This role is pivotal in optimizing and scaling up manufacturing processes for new and existing pharmaceutical products. You will be responsible for designing, implementing, and validating robust and efficient production methods that ensure product quality, safety, and cost-effectiveness. The successful candidate will work closely with research and development, quality assurance, and manufacturing teams to translate laboratory-scale processes into commercial-scale production. This is an excellent opportunity for an engineer passionate about process innovation and contributing to the reliable supply of essential medicines within Queenstown. Our client values technical expertise and a commitment to continuous improvement in all aspects of manufacturing.

Key Responsibilities

• Design, develop, and optimize manufacturing processes for pharmaceutical products, ensuring scalability and robustness.
• Conduct process validation studies, demonstrating that processes consistently produce products meeting predetermined specifications.
• Troubleshoot and resolve process-related issues during scale-up and commercial manufacturing.
• Collaborate with R&D to transfer new processes from lab scale to pilot and commercial scales.
• Develop and implement process improvements to enhance efficiency, yield, and cost-effectiveness.
• Prepare detailed process documentation, including batch records, SOPs, and validation protocols.
• Ensure all processes comply with cGMP, safety regulations, and environmental standards.
• Evaluate and recommend new technologies or equipment to improve manufacturing capabilities.
• Provide technical support to the manufacturing team in Queenstown, Eastern Cape.

Requirements

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline.
• Minimum of 4-6 years of experience in process development and scale-up within the pharmaceutical or related regulated industry.
• Strong understanding of cGMP, process validation principles, and relevant regulatory guidelines.
• Experience with unit operations common in pharmaceutical manufacturing (e.g., filtration, drying, mixing, granulation).
• Proficiency in process modeling and simulation software is a plus.
• Excellent analytical, problem-solving, and project management skills.
• Strong written and verbal communication skills for documentation and team collaboration.
• Ability to work effectively in a fast-paced, team-oriented environment in Queenstown.
• Familiarity with aseptic processing techniques is advantageous.

Benefits

• Our client offers a competitive salary and a comprehensive benefits package, including medical aid, retirement savings plan, and performance incentives.
• Opportunities for professional development, including specialized training and certifications, are provided.
• We cultivate a collaborative and safety-conscious work environment dedicated to innovation and quality.
• Generous paid time off and support for work-life balance are key priorities.
• Employees will have access to modern facilities and the chance to work on impactful pharmaceutical manufacturing projects in Eastern Cape.
• This role is based on-site in Queenstown to ensure close collaboration with manufacturing operations.