Engineer II, Sterile Process Engineering
3 weeks ago
Engineer II, Sterile Process Engineering
Foster City, CA
Schedule: Standard Office Hours
Duration: 18-months
Pay: $51-56/hr
Job Responsibilities:
In this role, you will contribute to the development and optimization of processes and systems for sterile drug products, collaborating closely with formulation scientists and manufacturing teams. Key responsibilities include:
- Designing, developing, scaling up, and validating processes for sterile drug product operations, including refrigerated/frozen storage, dissolution of active pharmaceutical ingredients (APIs), pooling and mixing, sterile filtration, filling, pre-filled syringe processing, lyophilization, and vial capping for both small molecule and large molecule parenterals.
- Conducting studies and generating reports on container closure system compatibility and sterile process engineering.
- Authoring and maintaining specifications for container closure system components, such as vials, stoppers, seals, and syringe plungers.
Essential Duties and Job Functions:
- Apply engineering principles to address technical challenges and drive process improvements.
- Execute studies and prepare clear, concise documentation adhering to good laboratory practices (GLP).
- Collaborate with cross-functional teams to ensure the successful development and implementation of processes.
- Proactively identify and address potential challenges, offering innovative solutions.
- Stay current with relevant scientific literature to ensure best practices in sterile process engineering.
Knowledge & Skills:
- Strong verbal and written communication skills with the ability to write error-free documentation.
- Capable of making informed decisions within established guidelines and procedures.
- Demonstrated ability to work collaboratively and manage competing priorities in a dynamic environment.
Education & Experience:
- Bachelor's degree in chemical engineering, bioengineering, material science, or a related field with at least 4 years of relevant experience, OR
- Master's degree in the same fields with at least 2 years of relevant experience.
Top 3 Required Skills:
- Experience in pharmaceutical parenteral formulations and/or drug product sterile process engineering.
- Laboratory experience with hands-on execution of studies using GLP.
- Proficiency in authoring protocols and reports for technical processes.
Preferred Qualifications:
- Familiarity with regulatory requirements and standards for sterile drug products.
- Experience with container closure system development and testing.
- Knowledge of Six Sigma, Lean principles, or similar process optimization methodologies.
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