Process Engineer – Sterile Compounding

Job Description

REQUIREMENTS

• 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, filter integrity testing, and single-use vs. reusable component systems.
• Strong understanding of USP <797>, <800>, cGMP, FDA 21 CFR Part 210/211, and ISO 14644 standards.
• Proficiency in AutoCAD, Microsoft Office Suite, and documentation systems such as Veeva or MasterControl.
• Strong analytical and problem-solving skills, with the ability to troubleshoot complex technical issues.
• Excellent written and verbal communication skills and the ability to work effectively across cross-functional teams.
• Hands-on experience supporting 503A and/or 503B compounding operations, with working knowledge of USP <795>, <797>, <800>, cGMP, and pharmacy regulatory standards.
• Demonstrated experience managing or supporting facility design, validation (IQ/OQ/PQ), cleanroom qualification, HVAC balancing, pressure differential control, and other pharmacy engineering systems.
• Advanced knowledge of Lean, Six Sigma, and Kaizen methodologies, with a track record of executing large-scale process improvements and continuous improvement initiatives.
• Expertise in sterile and/or non-sterile pharmacy workflows, compounding suite design, hazardous drug handling, and regulatory readiness.
• Strong skills in process mapping, data analysis, root cause analysis, and the use of statistical tools for performance improvement. Experience with AutoCAD or other facility layout and engineering design tools.
• Excellent cross-functional leadership and stakeholder management skills, with the ability to influence operations, quality, and pharmacy teams.
• Willingness to travel as required for vendor FATs and document punch list items for correction.

RESPONSIBILITIES

Process Design & Optimization

• 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.

Sterile Compounding & Aseptic Practices

• 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 <797>, <800>, NIOSH, and cGMP requirements for hazardous drug handling and containment.

Equipment & Facility Support

• 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.

Process Validation & Equipment Qualification

• 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.

Regulatory Compliance & Documentation

• Ensure all activities comply with USP <797>, <800>, FDA cGMP, and ISO standards (e.g., ISO 14644).
• Prepare and maintain SOPs, risk assessments, deviation reports, CAPAs, and change control documentation.

Technology Transfer & Collaboration

• 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.

Troubleshooting & Continuous Improvement

• 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.

Audit Readiness

• 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.

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