OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team as an Engineer II, Sterile Process Engineering in Foster City, CA. The Engineer II role will focus on the development of sterile drug product processes and container closure systems (e.g., vials, elastomeric stoppers, pre-filled syringes). Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
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.
EXPERIENCE & EDUCATION
• A Bachelors 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 Masters Degree in chemical engineering, bioengineering, material science, or a related scientific field and a minimum of two (2) years of relevant industry experience.
To be a best-fit your strengths must include:
• 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.
• Experience in pharmaceutical parenteral formulations and/or drug product sterile process engineering.
• Authoring protocols, reports, and execute studies using good laboratory practices (GLP).
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.