Principal Pharmaceutical Process Engineer

Placements24; Willows (CA); On-site; USD 73,000 - 109,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Paid time off

Relocation assistance

Training & conferences

Job summary

Placements24 seeks a Principal Pharmaceutical Process Engineer to design, optimize, and scale complex manufacturing processes in Welkom, Free State. You will lead cross‑functional teams, mentor engineers, and ensure GMP and regulatory compliance.

You will develop PFDs/P&IDs, oversee validation activities, and drive process improvements for solid dosage, sterile products, or biologics, leveraging advanced simulation tools and SPC.

Qualifications

• Advanced degree in chemical or mechanical engineering.
• 10+ years in pharmaceutical process engineering with design, scale‑up and validation.
• GMP/FDA/EMA knowledge and regulatory familiarity.
• Experience with aseptic processing or biologics is a plus.
• PE certification desirable.

Responsibilities

• Lead design, development, and optimization of pharmaceutical processes for dosage forms.
• Develop PFDs and P&IDs with robust process controls.
• Perform PHAs and embed safety in designs.
• Oversee process validation protocols, reports, and execution.
• Troubleshoot complex manufacturing issues and drive improvements.
• Collaborate with vendors, QA, and manufacturing teams.
• Mentor junior engineers and lead cross‑functional teams.
• Ensure GMP, FDA, EMA compliance and stay current with industry practices.

Skills

Cross-functional leadership

Data-driven decisions

Analytical skills

Communication skills

Problem solving

Team mentoring

Education

Master's or Ph.D. in Chemical/Mechanical Eng

Tools

Process simulation software

Statistical Process Control (SPC)

Job description

About the Role

Our client, a leading innovator in the pharmaceutical manufacturing sector, is seeking a highly experienced Principal Pharmaceutical Process Engineer to join their esteemed team in Welkom, Free State. This critical role will be responsible for designing, optimizing, and scaling up complex pharmaceutical manufacturing processes to ensure efficiency, quality, and compliance. You will leverage your deep technical expertise in process engineering principles, GMP, and regulatory standards to drive continuous improvement initiatives. The successful candidate will lead cross-functional teams, mentor junior engineers, and provide strategic input on process development and validation activities. This position offers a unique opportunity to work with cutting-edge technologies and contribute to the production of essential medicines at our Welkom, Free State facility.

Key Responsibilities

• Lead the design, development, and optimization of pharmaceutical manufacturing processes for solid dosage forms, sterile products, or biologics.
• Develop process flow diagrams (PFDs) and piping and instrumentation diagrams (P&IDs).
• Perform process hazard analyses (PHAs) and ensure safety considerations are integrated into process designs.
• Oversee process validation activities, including the development of protocols and reports, and execution of validation runs.
• Troubleshoot and resolve complex process-related issues encountered during manufacturing operations.
• Identify opportunities for process improvements to enhance yield, reduce costs, and improve efficiency.
• Collaborate closely with equipment vendors, engineering, quality assurance, and manufacturing teams.
• Mentor and guide junior process engineers, fostering their technical and professional development.
• Ensure all process designs and operations comply with GMP, FDA, EMA, and other relevant regulatory requirements.
• Stay current with emerging technologies and industry best practices in pharmaceutical manufacturing.

Requirements

• Master's degree or Ph.D. in Chemical Engineering, Mechanical Engineering, or a related field.
• Minimum of 10 years of progressive experience in pharmaceutical process engineering, with a strong emphasis on process design, scale-up, and validation.
• Extensive knowledge of pharmaceutical manufacturing equipment (e.g., reactors, filtration systems, dryers, tablet presses, filling lines).
• In-depth understanding of GMP regulations, FDA guidelines, and industry standards.
• Proven experience with process simulation software and statistical process control (SPC).
• Demonstrated ability to lead cross-functional project teams and manage complex technical challenges.
• Strong analytical and problem-solving skills, with a data-driven approach to decision-making.
• Excellent communication, interpersonal, and presentation skills.
• Experience with aseptic processing or biologics manufacturing is a significant plus.
• Professional Engineer (PE) certification is desirable.

Benefits

• Highly competitive salary package with performance-based incentives.
• Comprehensive health, dental, and vision insurance plans.
• Retirement savings plan and generous company contributions.
• Significant paid time off and holidays.
• Opportunities for advanced training, professional development, and conference attendance.
• Access to advanced manufacturing technologies at our Welkom, Free State site.
• Relocation assistance for eligible candidates.