Process Engineer - Biotech

Job Title: Process Engineer - Biotech (Fill Finish & Lyophilization)

Location: Ireland

Position Overview:

We are looking for a motivated and detail-oriented Process Engineer with a strong background in biotech processes, particularly in Fill Finish and Lyophilization. The successful candidate will play a critical role in optimizing and validating processes, ensuring compliance with industry standards, and contributing to the overall success of our clients projects.

Key Responsibilities:

- Design, evaluate, and optimize Fill Finish and Lyophilization processes for biologic products.

- Conduct process development and scale-up activities to improve production efficiency and product quality.

- Collaborate with cross-functional teams including Quality Assurance, Manufacturing, and Regulatory Affairs to ensure compliance with GMP and other regulatory frameworks.

- Perform process characterization, validation, and troubleshooting to identify and resolve production issues.

- Develop and implement standard operating procedures (SOPs) and work instructions related to Fill Finish and Lyophilization processes.

- Analyze data and present findings to stakeholders, using statistical tools and process modeling as necessary.

- Conduct risk assessments and implement continuous improvement initiatives in accordance with industry best practices.

Qualifications:

- Bachelors degree in Chemical Engineering, Biotechnology, Biochemistry, or a related field. 

- Minimum of 4 years of experience as a Process Engineer in the biotech industry, specifically with a focus on Fill Finish and Lyophilization processes.

- Strong knowledge of sterilization processes, aseptic techniques, and equipment used in Fill Finish operations.

- Proven experience in process validation and compliance with regulatory standards (FDA, EMA, ICH, etc.).

- Proficient with statistical analysis tools and software for process optimization.

- Excellent problem-solving skills with a proactive approach to process improvement.

- Strong communication skills with the ability to collaborate effectively across interdisciplinary teams.

Application Process:

Please submit CV to harry.miles@sourcingsegments.com 

Alternatively apply through application link at www.sourcingsegments.com/jobs