Process Engineer – Sterile Compounding- Mesa,AZ

About the Role:

We are seeking a skilled and detail‑oriented Process Engineer to support sterile injectable compounding operations within our 503A and 503B facilities. This role requires hands‑on experience in sterile injectable manufacturing, including both hazardous (HD) and non‑hazardous (NHD) drug products. The ideal candidate will be responsible for designing, optimizing, and validating aseptic processes, with a deep understanding of laminar airflow hoods, oRABS, fluid path design, filter integrity testing, and the selection and management of single‑use versus reusable components.

• Design and optimize sterile injectable compounding processes for HD and NHD products, focusing on aseptic technique, fluid path design, and containment.
• Select and integrate equipment including laminar flow hoods, oRABS, peristaltic pumps, and filtration units with consideration for single‑use vs. reusable components.
• Perform risk assessments (e.g., FMEA), identify CPPs and CQAs, and apply Lean and Six Sigma methodologies.
• Conduct time studies, process mapping, and capacity analysis to streamline batch production and reduce waste.
• Apply principles of lean manufacturing and continuous improvement (Kaizen, Six Sigma) to compounding and fill/finish workflows.

• Support aseptic technique development and batch execution for terminally sterilized and aseptically filled products.
• Collaborate with cleanroom personnel on proper gowning, material/personnel flow, and HEPA‑filtered environment controls.
• Work with QA to ensure compliance with USP , , NIOSH, and cGMP requirements for hazardous drug handling and containment.

• Specify and support installation and qualification of compounding equipment such as biosafety cabinets (BSCs), laminar airflow workstations (LAFW), autoclaves, filtration units, and isolators.
• Partner with validation teams on IQ/OQ/PQ for sterile compounding equipment and critical systems.
• Assist in airflow visualization studies, pressure differential control, and HVAC balancing for sterile suites.

• Develop process validation protocols (PV) for new and existing products and participate in execution and data analysis.
• Author and maintain SOPs, batch records, deviation reports, and process change documentation in compliance with internal procedures and regulatory expectations.
• Support cleaning validation, media fill simulations, and environmental monitoring investigations when deviations occur.
• Participate in IQOQ execution activities onsite for protocol execution and work with QA teams to ensure requirements are checked per compliance and signoff is obtained.

• Ensure all activities comply with USP , , FDA cGMP, and ISO standards (e.g., ISO 14644).
• Prepare and maintain SOPs, risk assessments, deviation reports, CAPAs, and change control documentation.

• Lead technology transfer efforts for new injectable products into manufacturing.
• Collaborate with QA, validation, pharmacy, engineering, and manufacturing teams to ensure successful implementation and operational readiness.

• Analyze process data to monitor trends and drive continuous improvement in compounding performance and efficiency.
• Troubleshoot equipment malfunctions, process deviations, and facility issues impacting sterile production.

• Ensure documentation and systems are audit‑ready for internal audits and external inspections by FDA or State Boards.
• Participate in regulatory inspections and provide technical support regarding process design and validation.

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related technical discipline.
• 5+ years of hands‑on experience in sterile injectable pharmaceutical manufacturing, including 503A or 503B operations.
• In‑depth knowledge of aseptic processing, cleanroom practices, hazardous drug handling, and fill/finish production.
• Experience with laminar airflow hoods, oRABS, fluid path design,…