Pharmaceutical Process Development Engineer

Placements24; United States; Hybrid; USD 120,000 - 190,000; Full time

Benefits offered by this job

Health insurance

Retirement plan with company match

Paid time off

Job summary

Placements24 seeks a Pharmaceutical Process Development Engineer to join a hybrid team, designing, optimizing, and scaling pharmaceutical manufacturing processes for solid dosage, sterile, or biologic products.

The role requires 4–6 years in process development, strong GMP knowledge, and collaboration across R&D, QA, QC, and Manufacturing in a hybrid environment.

Qualifications

• Bachelor's or Master's in Chemical Engineering, Pharmaceutical Engineering, or related field.
• 4–6 years of process development experience in pharma/biopharma.
• Experience scaling up pharmaceutical manufacturing processes.
• Strong knowledge of GMP applications in process development.
• Familiarity with granulation, compression, sterile filling, lyophilization.

Responsibilities

• Design, develop, and optimize manufacturing processes for pharma products with scalability and robustness.
• Conduct process development studies including parameter optimization and cost-reduction initiatives.
• Lead process scale-up activities from pilot plant to commercial manufacturing.
• Develop and validate new manufacturing equipment and technologies.
• Generate process documentation: batch records, validation protocols, and reports.
• Troubleshoot deviations and implement CAPA with cross-functional teams.
• Collaborate with R&D, QA, QC, Manufacturing for tech transfer; ensure GMP compliance.
• Support process validation activities and regulatory submissions.

Skills

Process development

Scale-up

GMP

Chemical engineering

Statistical analysis

Education

BSc or MSc in Chemical/Pharma Eng

Tools

JMP

Minitab

Job description

About the Role

Our client, a forward-thinking pharmaceutical manufacturing company, is seeking a talented Pharmaceutical Process Development Engineer to join their innovative team in Welkom, Free State. This hybrid role allows for a blend of on-site work at our advanced manufacturing facility and remote work, offering flexibility while ensuring critical process development activities are conducted efficiently. You will be responsible for designing, optimizing, and scaling up manufacturing processes for pharmaceutical products, ensuring efficiency, quality, and compliance. This position requires a strong foundation in chemical engineering principles, combined with specific knowledge of pharmaceutical manufacturing operations, including solid dosage forms, sterile manufacturing, or biologics. You will work closely with formulation scientists, quality assurance, and manufacturing personnel to bring new products from laboratory scale to commercial production. This is an excellent opportunity to contribute to the development of life-changing medicines and advance your engineering career in a dynamic and supportive environment in Welkom. The company is committed to technological advancement and provides extensive resources for professional growth. Your expertise in process optimization and scale-up will be instrumental in our success.

Key Responsibilities

• Design, develop, and optimize manufacturing processes for pharmaceutical products, ensuring scalability and robustness.
• Conduct process development studies, including parameter optimization, yield improvement, and cost reduction initiatives.
• Lead and participate in process scale-up activities from pilot plant to commercial manufacturing.
• Develop and validate new manufacturing equipment and technologies.
• Generate process documentation, including batch records, validation protocols, and technical reports.
• Troubleshoot manufacturing process deviations and implement effective corrective and preventive actions (CAPA).
• Collaborate with cross-functional teams (R&D, QA, QC, Manufacturing) to ensure seamless technology transfer.
• Ensure all process development activities comply with Good Manufacturing Practices (GMP) and relevant regulatory guidelines.
• Stay current with industry trends, emerging technologies, and best practices in pharmaceutical process engineering.
• Conduct risk assessments for new and existing processes.
• Support process validation activities and regulatory submissions.

Requirements

• Bachelor's or Master's degree in Chemical Engineering, Pharmaceutical Engineering, or a related field.
• Minimum of 4-6 years of experience in process development within the pharmaceutical or biopharmaceutical industry.
• Proven experience in scaling up pharmaceutical manufacturing processes.
• Strong understanding of GMP regulations and their application to process development.
• Familiarity with various pharmaceutical manufacturing technologies (e.g., granulation, compression, sterile filling, lyophilization).
• Proficiency in process modeling, simulation, and statistical analysis tools (e.g., JMP, Minitab).
• Excellent problem-solving, analytical, and project management skills.
• Strong communication and interpersonal skills, with the ability to collaborate effectively in a hybrid team setting.
• Experience with technology transfer and process validation is highly desirable.
• Ability to work independently and manage multiple priorities in a dynamic environment.
• Must be able to commute to Welkom for on-site responsibilities as part of the hybrid work arrangement.

Benefits

• Our client provides a competitive salary package, recognizing the value of specialized engineering skills.
• Comprehensive health insurance coverage, including medical and optical benefits, is offered.
• A retirement savings plan with employer matching is available.
• Generous paid time off includes annual leave, sick days, and public holidays.
• Opportunities for professional development, including further education and specialized training, are supported.
• The hybrid work model offers valuable flexibility.
• Our client is committed to fostering a safe and healthy work environment.
• Potential for performance-based bonuses.
• Access to state-of-the-art facilities and equipment in Welkom.
• Opportunities for career advancement within a growing organization.
• Support for professional engineering body memberships.