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 :

1. Experience in pharmaceutical parenteral formulations and/or drug product sterile process engineering.
2. Laboratory experience with hands-on execution of studies using GLP.
3. 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.