Responsibilities:

• Excellent employment opportunity for an Engineer II, Sterile Process Engineering in the Foster City, CA area.
• 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).
• 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.

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.
• 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 to determine and take appropriate action.
• 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)