Lead Biopharmaceutical Process Engineer

Placements24; Cape Town; On-site; ZAR 1,200,000 - 2,400,000; Full time

Benefits offered by this job

Medical aid

Annual performance bonus

Annual leave

Training and conference attendance

Career progression opportunities

Job summary

Placements24 is seeking a Lead Biopharmaceutical Process Engineer to drive development, optimization, and scale-up of complex biopharmaceutical processes in a Cape Town facility. The role focuses on cell culture, fermentation, purification, and formulation with a strong emphasis on regulatory compliance and technology transfer.

The candidate will lead cross-functional teams, develop robust processes, and mentor junior engineers while staying ahead of bioprocessing innovations.

Qualifications

• Master's or PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related discipline.
• 10+ years of hands-on biopharmaceutical process development and manufacturing experience.
• Strong knowledge of upstream and downstream bioprocessing operations.
• Proven experience in scale-up, technology transfer, and validation.
• Solid understanding of cGMP regulations for biologics.
• Excellent analytical and problem-solving skills with a data-driven approach.
• Demonstrated leadership and team management.
• Strong written and verbal communication skills.

Responsibilities

• Lead development, optimization, and scale-up of biopharmaceutical manufacturing processes (cell culture, fermentation, purification, formulation).
• Design and execute process validation studies and technology transfer activities.
• Troubleshoot complex process-related manufacturing issues.
• Develop and implement process improvements for yield, purity, and cost optimization.
• Ensure compliance with cGMP, regulatory guidelines (SAHPRA, FDA, EMA) and SOPs.
• Author/review development reports, validation documents, and regulatory submissions.
• Collaborate with R&D, manufacturing, QA/QC teams.
• Mentor junior engineers and technical staff.

Skills

Leadership

Bioprocessing knowledge

Analytical thinking

Data-driven

Communication skills

Education

Master's or PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, or related

Tools

Process modeling tools

Job description

About the Role

Our client, a pioneering biopharmaceutical company, is looking for an accomplished Lead Biopharmaceutical Process Engineer to spearhead process development and optimization in their state-of-the-art facility in Cape Town, Western Cape . This senior position demands extensive expertise in bioprocessing, scale-up, and manufacturing of complex biological therapeutics. The successful candidate will play a crucial role in ensuring the efficient, compliant, and cost-effective production of innovative medicines. This is a fantastic chance to join a forward-thinking organization and contribute to groundbreaking advancements in biotechnology. The role is based onsite in beautiful Cape Town , offering an unparalleled work environment.

Key Responsibilities

• Lead the development, optimization, and scale-up of biopharmaceutical manufacturing processes, including cell culture, fermentation, purification, and formulation.
• Design and execute process validation studies and technology transfer activities.
• Troubleshoot and resolve complex process-related issues encountered during manufacturing.
• Develop and implement process improvements to enhance yield, purity, and cost-effectiveness.
• Ensure all process activities comply with current Good Manufacturing Practices (cGMP), regulatory guidelines (e.g., SAHPRA, FDA, EMA), and internal SOPs.
• Author and review process development reports, validation documents, and regulatory submissions.
• Collaborate closely with R&D, manufacturing operations, quality control, and quality assurance teams.
• Mentor and guide junior engineers and technical staff, fostering their professional growth.
• Stay abreast of emerging technologies and industry trends in biopharmaceutical manufacturing.

Requirements

• Master's or Ph.D. in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related discipline.
• A minimum of 10 years of hands-on experience in biopharmaceutical process development and manufacturing.
• In-depth knowledge of upstream and downstream bioprocessing unit operations.
• Proven experience in process scale-up, technology transfer, and validation.
• Strong understanding of cGMP regulations and guidelines relevant to biologics.
• Excellent analytical and problem-solving skills, with a data-driven approach.
• Demonstrated leadership capabilities and experience managing technical teams.
• Exceptional written and verbal communication skills.
• Familiarity with process modeling and simulation tools is desirable.
• Must be willing to work onsite in Cape Town, Western Cape .

Benefits

We offer a highly competitive salary package, with an annual remuneration of R , reflecting your expertise and contribution. In addition to the salary, employees receive comprehensive medical aid coverage, an annual performance bonus, ample annual leave, and opportunities for advanced training and conference attendance. Our client fosters a collaborative and innovative workplace culture, encouraging professional development and career progression within the exciting field of biopharmaceuticals. This role offers the unique opportunity to work at the forefront of biotechnology in a stunning coastal city.