Full Description

Process Validation Engineer (Biotech/Pharma) Location – California Bay Area

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!

Ideal candidate will have a minimum of 5 years’ experience supporting the validation of new product introductions into an existing biologics manufacturing facility. Should demonstrate an understanding of process and cleaning validation principles. At a minimum the candidate should have experience with biologics. Cell therapy and gene therapy experience is a plus.

Job Duties

• Requires a bachelor’s or master’s degree in Scientific (Biotechnology) or Engineering (Mechanical, Chemical or Biochemical Engineering) degree.
• Minimum of 5+ years' experience in the biotech-pharmaceutical environment.
• Review and contribute to process descriptions and process risk assessments to identify critical process parameter ranges and critical quality attributes
• Develop process performance qualification protocols, validation rationale, sampling plans, and acceptance criteria.
• Execute process validation protocols along with engineering or PPQ runs
• Summarize QC assay results in the form of a validation summary report
• Develop cleaning validation protocols, assess worst case soiling material, define dirty hold and clean hold times.
• Develop cleaning validation sampling plan and sampling assays with acceptance criteria based maximum allowable carry-over calculations
• Execute mock soiling, observe and document automated cleaning cycles, obtain final rinse and swab samples
• Analyze QC assay results and document cleaning validation cycle parameters, clean and dirty hold times.