Sterile Process Engineer

3 weeks ago

San Mateo CA United States US Tech Solutions Full time

Duration: 06 months contract



Job Description:

research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
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).



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.



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.
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).



Education:

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.





About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.



US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.



Recruiter Details:

Name: Rudra

Email: Rudra.sarkar@ustechsolutionsinc.com

Internal Id: 24-27953

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