Title: Engineer II, Sterile Process Engineering

Location: Foster City, CA

Duration: 18 months contract

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.

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)