Senior Process Engineer

Job Title: Senior Process Engineer (Pharmaceutical Technology)

Department: Pharmaceutical Technology

Reporting To: Director, Pharmaceutics

Classification: Exempt

Salary Range: 96k-118k

What We Do

BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees. Our US operations are US headquartered in Irvine, CA. Our 10 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.

Why BioDuro-Sundia?

Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.

Job Overview/Summary

The Senior Process Engineer, under minimal general direction, independently performs various duties related to optimization and analysis of production processes, new products and processes, and technology transfers. Provides support for troubleshooting and improvements to existing products and processes. This individual contributor supports routine commercial manufacturing, lead late-stage and commercial technology transfers, support process scale-ups, and complete process validation activities.

Essential Functions and Responsibilities

• Prepare and execute engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final summary reports for marketed and new products.
• Coordinate with Facilities, Engineering, Manufacturing, Packaging, Product Development, Analytical Services, RA, and QA to initiate manufacturing and packaging experimental / feasibility study / validation projects for marketed and new products.

• Perform on-site and site-change technical transfer, scale-up or scale-down factor evaluation, manufacturing / packaging process and equipment troubleshooting, and SOP preparation and review.
• Conduct formulation development and evaluation for marketed and new products.
• Troubleshoot the setup and operation of manufacturing/packaging equipment and the process of new R&D projects.
• Conduct investigations on deviations.
• Evaluate and troubleshoot mid to high level manufacturing / packaging equipment and process issues.
• Work on problems of increasing complexity where analysis of situation or data requires review of identifiable factors. Recommend solutions to technical issues.
• Conduct training to related department personnel on all technical and project-related documents, such as batch records, protocols, and SOP etc.
• Frequently interact with team members, supervisors, outside customers/vendors, & other teams/departments. Interaction normally requires the ability to gain cooperation of other departments, conducting presentations of technical information concerning specific projects/schedules, etc.
• This job description is subject to change at any time.

Requirements

• BS degree in Engineering or Chemical Engineering preferred with 8+ years’ related experience OR
• MS with 5+ years’ experience as noted above OR
• PhD with 2-3 years of experience as noted above.
• Experience with process validation and commercial manufacturing
• Direct hands-on experience within a manufacturing environment
• Experience with scale-up and scale-down models
• Knowledgeable of QbD, Current Good Manufacturing Practices (cGMP), FDA, OSHA, EPA, DEA; other regulatory requirements.
• Complete understanding of Pharmaceuticals manufacturing principles, practices and applications.
• Working knowledge of Analytical test methodology (BU, Assay, CU and dissolution profile, etc.).
• Understanding of concepts of equipment qualification/calibration.
• Understanding of computer validation concepts.
• Intermediate statistical computations (Cp, Cpk, regression analysis, etc.); use of statistical software.
• Personal computer operations and MS