What are the responsibilities and job description for the Process Engineer position at XYZ?
Job Title : Engineer II, Sterile Process Engineering
Location : 333 Lakeside Drive, Foster City, CA
Duration : 18 Months
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 parenteral
- 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 :
Required Education & Experience
Top 3 Required Skill Sets :
