Biotech Manufacturing Engineer
This role involves the design, development, and implementation of manufacturing processes, equipment, and systems in the biotechnology industry.
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Sample Job Descriptions for Biotech Manufacturing Engineer
Below are the some sample job descriptions for the different experience levels, where you can find the summary of the role, required skills, qualifications, and responsibilities.
Junior (0-2 years of experience)
Summary of the Role
This role involves working closely with a team to design, test, and implement processes and equipment used in the production of pharmaceutical and medical products. The candidate will contribute to the development of biotechnology products by applying principles of biology and engineering.
Required Skills
- Proficiency in data analysis and process simulation software.
- Strong technical writing and communication abilities.
- Technical understanding of bioprocessing equipment.
- Capacity to design and conduct experiments.
- Knowledge of process validation principles.
Qualifications
- Bachelor's degree in Biomedical Engineering, Biochemical Engineering, Biotechnology, or a related field.
- Understanding of Good Manufacturing Practices (GMP) and experience in a regulated industry is advantageous.
- Familiarity with biotechnology, cell culture processes, and biochemical analysis.
- Strong analytical and problem-solving skills.
- Ability to work in a fast-paced, team-oriented environment.
Responsibilities
- Assisting in the development and scale-up of manufacturing processes for biotechnological products.
- Supporting the implementation of new production equipment, including setup, calibration, and validation.
- Collaborating with research and development (R&D) teams to translate laboratory processes to full-scale production.
- Ensuring compliance with regulatory standards such as FDA or EMA guidelines.
- Participating in trouble-shooting and problem-solving for manufacturing issues.
- Conducting process optimization experiments to improve product yield and quality.
- Working with cross-functional teams to ensure integration of biotechnological processes.
- Assisting in the preparation and review of process documentation and reports.
Intermediate (2-5 years of experience)
Summary of the Role
The Biotech Manufacturing Engineer is responsible for designing, implementing, and optimizing biotechnological manufacturing processes. They work closely with interdepartmental teams to ensure that production is efficient, cost-effective, and meets quality standards.
Required Skills
- Strong analytical and problem-solving skills.
- Proficiency in statistical software and data analysis tools.
- Excellent communication and documentation skills.
- Ability to work collaboratively in a team environment.
- Time management skills to meet project timelines.
- Adaptability to quickly changing priorities and regulations.
Qualifications
- Bachelor's degree in biochemical engineering, biotechnology, or related field.
- 2-5 years of experience in a manufacturing environment within the biotechnology or pharmaceutical industry.
- Knowledge of FDA regulations and Good Manufacturing Practices (GMP).
- Experience with bioreactor operation and scale-up processes.
- Proven ability to design and execute process validation studies.
- Solid understanding of statistical process control and design of experiments (DOE).
Responsibilities
- Develop and improve manufacturing processes for biotechnological products.
- Work with cross-functional teams to transfer new products and processes from development to commercial scale.
- Design and perform experiments to troubleshoot manufacturing issues and drive process improvements.
- Ensure compliance with regulatory standards such as FDA, EMA, and GMP.
- Create and maintain documentation for manufacturing processes and equipment.
- Implement process controls to ensure consistent product quality.
- Collaborate with quality teams to identify and mitigate risks in the manufacturing process.
- Evaluate new technologies and equipment for potential adoption into manufacturing.
- Provide technical support and training to manufacturing personnel.
Senior (5+ years of experience)
Summary of the Role
We are seeking a seasoned Biotech Manufacturing Engineer with a proven track record in biotechnology or pharmaceutical manufacturing to join our dynamic team. The successful candidate will drive manufacturing processes, ensure compliance with industry standards, and lead engineering initiatives to improve product quality and production efficiency.
Required Skills
- Strong analytical and problem-solving skills.
- Excellent leadership and interpersonal communication skills.
- Proficiency with statistical software and process simulation tools.
- Knowledge of bioprocess engineering principles.
- Ability to work independently and as part of a team.
- Attention to detail and ability to manage multiple projects simultaneously.
- Familiarity with continuous improvement methodologies such as Lean Six Sigma.
Qualifications
- Bachelor's degree in Chemical Engineering, Biomedical Engineering, Biotechnology or a related field.
- Master's degree or PhD preferred.
- Minimum of 5 years' experience in biotech or pharmaceutical manufacturing engineering.
- Strong understanding of GMP and regulatory requirements applicable to biotechnology or pharmaceutical manufacturing.
- Proven experience in the scale-up of biotechnological processes.
- Experience in process validation and equipment qualification.
- Demonstrated ability to lead and manage projects.
Responsibilities
- Oversee and optimize biotech manufacturing processes for maximum efficiency and compliance with Good Manufacturing Practice (GMP).
- Develop and implement process improvement projects to increase yield, reduce costs, and improve quality.
- Provide technical leadership and support for the manufacturing team and cross-functional project teams.
- Collaborate with R&D to scale up production processes from lab to manufacturing scale.
- Manage the installation, validation, and maintenance of manufacturing equipment.
- Lead root cause analysis for process deviations and implement corrective and preventive actions (CAPAs).
- Ensure compliance with all environmental, health, and safety regulations in the manufacturing environment.
- Prepare and review technical documentation including SOPs, batch records, and engineering reports.
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