RCI-GILD-15984-Sterile Process Engineer-Foster City, CA at Rangam Infotech Private Limited

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Engineer II, Sterile Process Engineering

Summary:

• We are seeking an Engineer II to join our Sterile Process Engineering group acting as an interface between formulation scientists and manufacturing operations.
• Qualified candidates will focus on the development of sterile drug product processes and container closure systems (e.g., vials, elastomeric stoppers, pre-filled syringes).

Specific Job Responsibilities:

• Apply fundamental engineering principles to the design, development, scale-up, and validation of processes for sterile drug product unit operations (e.g., refrigerated/frozen storage and handling of bulk solutions, dissolution of APIs, pooling and mixing, sterile filtration, filling, pre-filled syringe processing, lyophilization, and vial capping) for both small molecule and large molecule parenterals
• Execute studies and author reports related to container closure system compatibility and sterile process engineering
• Author and maintain internal specifications for container closure system components (vials, stoppers, seals, pre-filled syringes, plungers, etc…)
• Qualified candidates should be self-motivated and organized, knowledgeable of relevant scientific literature, passionate about scientific inquiry and investigation, proactive in identifying and addressing potential challenges, and collaborative in driving solutions.

Knowledge & Skills:

• Strong verbal, written, and interpersonal communication skills are required.
• Must be able to write clear, concise, and error-free documents.
• Must be able to exercise judgment within well-defined and established procedures and policies in order to determine and take appropriate action.

Required Education & Experience:

• A Bachelor’s Degree in chemical engineering, bioengineering, material science, or a related scientific field and a minimum of four (4) years of relevant industry experience OR a Master’s Degree in chemical engineering, bioengineering, material science, or a related scientific field and a minimum of two (2) years of relevant industry experience.

Top 3 Required Skill Sets:

• Lab-based role and must have experience in pharmaceutical parenteral formulations and/or drug product sterile process engineering
• Author protocols, reports, and execute studies using good laboratory practices (GLP)