Process Engineer​/Senior Process Engineer- Las Vegas

About the job

Anazao Health is a 503B outsourcing facility in Las Vegas, Nevada. The Process Engineer / Senior Process Engineer will report to the Facilities and Engineering Manager and will be responsible for leading process design initiatives, managing the technical and regulatory aspects of process development, scale up, and production-scale process validation in support of solid dose and injectables manufacturing, and providing hands‑on support and technical expertise to manufacturing.

This role will work cross‑functionally between Engineering, Production, and Quality and act as the team lead to ensure the timely and successful completion of projects.

• Design and develop new processes in line with business needs.
• Manage product process development through scale up and process validation.
• Oversee existing process validation schedule to ensure timelines are met and that manufacturing processes are robust and scalable.
• Author and review GMP documentation related to process development and validation (protocols, SOPs, Master Batch Records, Change Controls, etc.).
• Identify equipment required for manufacturing scale-up and work with the Global Automation team to define User Specification Requirements.
• Identify key data collection points within production and create standard methods for collecting and analyzing.
• Work cross‑functionally as needed to ensure seamless equipment and process implementation to manufacturing operations.
• Monitor and routinely report on processes performance in the form of periodic presentations.
• Support day‑to‑day operations by providing expertise for deviation investigations, process troubleshooting, and optimization opportunities.
• Provide budgets and timelines for new projects with regularly scheduled deliverables.
• Verify all regulatory requirements set by governing bodies (FDA, EU, EPA, etc.) are met during process validation and commissioning work.
• Maintain a positive and professional attitude when working with peers.
• Provide technical support and expertise to other departments as needed.

Note:

The above statements describe the general nature and level of the work being performed and are not an exhaustive list of all responsibilities of an employee in this job. Job duties can change at any time as directed by management. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the employer.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor of Science degree in Biotechnology, Biological or Pharmaceutical Sciences, or Engineering (chemical, biological, or mechanical). Chemical Engineering degree preferred.
• 5 – 7 years of experience in a pharmaceutical GMP environment (process development, process validation, scale up, and/or technology transfer).
• Previous work in a validation or process engineering‑type role is required.
• Proficient in Microsoft Office (Excel, Word, Access).
• Some working knowledge of statistical analysis & programming platforms (JMP, Minitab, MATLAB, R).
• Strong technical writing skills.
• Strong communication skills.

offers competitive salaries and a comprehensive benefit package to include 401(k), health insurance coverage for you and your dependents, paid holidays, PTO, and Volunteer Paid Time Off.

Please include salary requirements. No phone calls, please. We are not accepting agency referrals for this position.