Process Engineer

Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered. ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects. ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies. The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set. This is an outstanding opportunity to join our growing team!💼 Full-Time | Onsite

About the Role: We are seeking a detail-oriented and technically proficient Process Engineer who will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

Responsibilities: Work with Upstream equipment Fermentation Process optimization Process scale-up or scale-down studies Commissioning and Qualification Protocol generation and execution Data analysis Report writing Author SOPsGreat communication skills (presenting, and writing)Protein expression/purification GxP (GDP, GLP, or GMP a major asset)

Minimum Requirements: Bachelor’s or master’s degree in Biochemistry, Biology, Mechanical Engineering, Chemical Engineering, Biochemical Engineering, or related discipline.

Required: 5+ years of experience in the biotech-pharmaceutical academic or industrial environment. Bioprocess experience preferred Fill finish experience preferred Basic knowledge of upstream/downstream drug substance manufacturing. Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations. Familiarity with ICH guidelines and EMA regulations is a plus. Basic technical writing with proficiency in Excel, Power Point, Visio, Word, Sharepoint, etc. in addition to experience working within shared work environments. Demonstrated experience with manufacturing processes and equipment such as CIP systems, bioreactors, filtration skids, chromatography and lyophilization equipment. Basic knowledge of the Commissioning and Qualification. Travel within USA as needed for the projects.

Perks & Benefits: Competitive salary Full health, dental, vision, and retirement benefits Tuition reimbursement, PTO, and more