Sterile Process Engineering Engineer II,

True Title: Engineer II, Sterile Process Engineering

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)