Foster City, CA, 94404, USA
8 days ago
Sterile Process Engineer
Job Title: Sterile Process EngineerJob Description 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.). + Self-motivation and organization are essential, along with a knowledge of relevant scientific literature, a passion for scientific inquiry and investigation, proactivity in identifying and addressing potential challenges, and collaboration in driving solutions. Essential Skills + Experience in pharmaceutical parenteral formulations and/or drug product sterile process engineering. + Ability to author protocols, reports, and execute studies using good laboratory practices (GLP). + Strong verbal, written, and interpersonal communication skills. + Ability to write clear, concise, and error-free documents. + Judgment skills within well-defined and established procedures and policies. Additional Skills & Qualifications + Bachelor’s Degree in chemical engineering, bioengineering, material science, or a related scientific field with a minimum of four (4) years of relevant industry experience. + Master’s Degree in chemical engineering, bioengineering, material science, or a related scientific field with a minimum of two (2) years of relevant industry experience. Work Environment This is a lab-based role where you will be working with various technologies and equipment related to sterile process engineering. The work environment requires adherence to good laboratory practices (GLP) and involves collaboration with formulation scientists and manufacturing operations. Pay and Benefits The pay range for this position is $56.93 - $56.93 • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Foster City,CA. Application Deadline This position will be accepting applications until Dec 24, 2024. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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