Role Overview
This position focuses on the engineering and technical oversight of aseptic compounding systems used in the production of sterile medications. The engineer will lead process design, validation, and lifecycle management activities to ensure compliance with regulatory standards and maintain the highest level of sterility assurance.
Key Responsibilities
- Develop and refine aseptic compounding workflows, facilities, and equipment to support sterile drug manufacturing.
- Support the selection, installation, and qualification of critical systems, including isolators, cleanroom utilities, and sterilization equipment.
- Lead or contribute to installation, operational, and performance qualification (IQ/OQ/PQ) activities for processes and equipment.
- Provide engineering expertise for HVAC systems, cleanroom environments, and utilities that impact sterility.
- Ensure adherence to USP <797>, USP <800>, FDA regulations, and current Good Manufacturing Practices (cGMP).
- Prepare, review, and approve standard operating procedures, validation protocols, risk assessments, and technical reports.
- Participate in media fill studies, environmental monitoring, gowning evaluations, and aseptic process simulations.
- Lead investigations into deviations, contamination events, and equipment failures using root cause analysis methods.
- Apply risk assessment tools such as FMEA to identify and reduce risks to product sterility.
- Drive process improvements to enhance efficiency, compliance, and operational reliability.
- Support audit readiness, regulatory inspections, and remediation efforts.
- Collaborate with cross-functional teams including Quality, Operations, Validation, and Facilities.
- Assist in technology transfer, process scale-up, and new product implementation.
- Maintain accurate, inspection-ready documentation and provide training to technical staff on aseptic practices.
- Stay informed about evolving regulatory expectations and emerging technologies in sterile manufacturing.
Qualifications
Required
- Bachelor’s degree in Engineering, Pharmaceutical Sciences, Pharmacy, or a related technical field.
- 1–3 years of experience in sterile compounding, pharmaceutical manufacturing, or cleanroom environments under cGMP.
- Familiarity with USP <797>, USP <800>, and aseptic processing principles.
- Hands-on experience with sterilization techniques such as steam, dry heat, and filtration.
- Proven experience supporting equipment qualification and process validation in regulated settings.
Preferred
- Master’s degree in Engineering or Pharmaceutical Sciences.
- Experience with RABS, isolator systems, single-use technologies, or automated aseptic systems.
- Training in Lean, Six Sigma, or formal risk management methodologies.
- Direct involvement in FDA inspections, regulatory audits, or corrective action initiatives.
Technical Expertise
USP <797>, USP <800>, cGMP, FDA regulations, IQ/OQ/PQ, FMEA, cleanroom systems, HVAC, critical utilities, aseptic processing equipment, sterilization methods (steam, dry heat, filtration), environmental monitoring, media fills, aseptic process simulations.
Work Environment
This is an on-site role with occasional off-hours or on-call support required for manufacturing operations and critical validation activities.
Company Culture
The organization emphasizes talent development, flexible work practices, and a strong commitment to quality, patient safety, and data integrity. Teams operate collaboratively across functions, with a focus on continuous improvement and precision in execution.
